Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults

Learn more about:
Related Clinical Trial
Pertussis Acellular Vaccine Adjuvanted With TQL1055 Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan A Multi-center Study to Determine the Prevalence and Influence of Pertussis on Subacute Cough in Shenzhen A Multi-center Study to Determine the Prevalence and Influence of Pertussis on COPD Exacerbation in Shenzhen Assessment, Feedback, Incentive, Exchange (AFIX OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years Maternal Pertussis Wholecell Responses Adacel® Booster Vaccination for CMI Assay Development Pathogenic Bordetella Rapid Detection 5-year Follow-up After a Single Dose Acellular Pertussis Vaccination Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly CD8 Reactivity to Microorganisms in Blood and Breast Milk Testing the Use of Prompts to Increase Adolescent Immunization Rates Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age Pilot Study Freeze and Transport Immune Cells Increasing Vaccine Uptake Among Veterans at the Atlanta VA Health Care System Seroimmunity 2007 and Sub Study of the Swedish Population Regarding Vaccine Preventable Disease Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants Immunogenicity and Safety of Sanofi Pasteur’s Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months. DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants Retrospective Survey of Safety of Fourth Dose Pentacel® in Children Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China Pentavalent DTaP-Hep B-IPV DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants Evaluation of an Infant Immunization Encouragement Program in Nigeria A Study to Compare LBVD to Eupenta and Imovax Polio in Healthy Adults Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™ Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants Study of the Environmental Factors Modulating Children Immune Response in Northern Senegal Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™ How Does the Clinical Tool ‘What’s Going Around’ Affect Clinical Practice Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs Immunology of Non-specific Effects of Vaccine Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants. Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar® Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth Immunogenicity and Safety of Pentaxim in South African Infants Immunogenicity and Safety of Pentaxim™ in an Indian Population Boostrix® Pregnancy Registry Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants Montelukast for Persistent Cough in Young People and Adults Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035) Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL® Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™ Database Surveillance Safety Study of PENTACEL® Vaccine A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject A Study to Assess the Immunogenicity and Safety of GSK Biologicals’ Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting Protecting Pregnant Women From Infectious Diseases A Study to Assess the Safety of Adacel® Vaccine Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV Immunogenicity and Safety of Adacel Polio Vaccine Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL® Confirmatory Study of BK1310 in Healthy Infants Study of the Tdap Combined Vaccine (ADACEL™) as a Booster Dose in Healthy Adults and Children in China Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED) Influence of BCG on TDaP-IPV Vaccination A Phase IV Study to Assess the Safety of EupentaTM Inj Phase I Clinical Trial in Healthy Children The Transparent Safety Study of the 5 in 1 (DTwP-rHepB-Hib) Combination Vaccine Produced by the Indian Serine Institute in Children of Viet Nam Healthy From 6 to 12 Weeks of Age in a 3-dose Regimen, the Interval Between Doses is 4 Weeks Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025) Maternal Antibody in Milk After Vaccination Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age Safety and Immune Response of Different Pediatric Combination Vaccines. Sanofi Pasteur’s Tdap Combined Vaccine as a Booster Versus Local DT Vaccine in Children or Versus Local Td Vaccine in Adolescents and Adults in China. Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED) Tdap Vaccination for Infant Caregivers Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX® TDAP Safety in Pregnant Women Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine The Safety of Boostrix Following Routine Immunization of Pregnant Women Regulatory Post-Marketing Surveillance Study for TETRAXIM™ Tdap Vaccine in Post-Partum Women Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents Post Marketing Surveillance for ADACEL™ in South Korea Vouchers to Promote Tdap Vaccination Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1) Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN) Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibodies Response After a Single Dose of Tdap Vaccine in Thai Pregnant Women Viaskin Pertussis Vaccine Trial Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine The Feasibility of Pertussis Immunization in a Canadian Emergency Department Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012) Safety and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines Assessing Contacts’ Decision Making on Reducing the Risk of Pertussis Transmission to Newborns Through Immunisation Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines Maternal Tdap Immunization in Guatemala Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B Study of SP306 Given Intramuscularly Compared to DT Given Subcutaneously in Japanese Adolescents 11 – 12 Years Old The PertADO Geneva Trial Study of Adacel® Vaccine Administered to Persons 10 Years of Age Pertussis Immunization During Pregnancy & HIV Infection Observational Study Describing the Immune Profile Induced By Pertussis Vaccines Sero-prevalence of Anti-pertussis Antibodies and Disease Awareness Among Spanish Healthcare Professionals Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis Pertussis and Meningitis C Concomitant Vaccination in Adolescents Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine 2-year Follow-up After a Single Dose Acellular Pertussis Vaccination Pertussis Vaccine in Healthy Pregnant Women Pertussis Vaccination in Pregnant Women A Study Exploring Whooping Cough Protection in Children and Adults Immunising Mums Against Pertussis 3 3-year Follow-up After a Single Dose Acellular Pertussis Vaccination A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine Optimising the Timing of Whooping Cough Immunisation in MUMs Bordetella Pertussis Colonisation Challenge Study Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines Gambia Pertussis Study (GaPs) A Phase 1/2 Clinical Trial of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults Vanderbilt Pertussis Exposure Study: PEP in Vaccinated Healthcare Workers Following Pertussis Exposure A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine Study of Adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine in Healthy 3 to 5 Months Infants Pertussis Infection in Adolescents and Adults With Prolonged Cough Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants First Adult Safety Trial on Nasal Live Attenuated B. Pertussis Vaccine The Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients Pertussis Immunization During Pregnancy: Effect in Term and Preterm Infants Pertussis (Tdap) Vaccination in Pregnancy

Brief Title

Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults

Official Title

Phase 2b Study of BPZE1 Intranasal Pertussis Vaccine in Adults to Assess Immunological Response and Safety Profile of 1-Dose (Prime) and 2-Doses (Prime+Boost) Schedule, Compared to a Boostrix™ Prime Dose With or Without a BPZE1 Boost Dose

Brief Summary

      This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis
      vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares
      a single (prime) BPZE1 dose or 2-dose (prime + boost) to a single (prime) Boostrix or BPZE1
      prime + Boostrix boost. This is a multi-center, randomized, placebo-controlled, and observer
      blinded trial in healthy adults with a 6 month safety follow-up after the last vaccination.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Immunogenicity - Mucosal Seroconversion

Secondary Outcome

 Systemic Immunogenicity - seroconversion to 1 or more antigens

Condition

Pertussis

Intervention

BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device

Study Arms / Comparison Groups

 BPZE1 Intranasal Prime, BPZE1 Boost
Description:  Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of intramuscular (I.M.) placebo. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Combination Product

Estimated Enrollment

300

Start Date

June 15, 2019

Completion Date

June 24, 2020

Primary Completion Date

February 14, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Is a male or nonpregnant female 18 to 50 years of age, inclusive, on Day 1 (primary
             vaccination).

          2. Is capable of understanding the written informed consent, provides signed and
             witnessed written informed consent, and agrees to comply with protocol requirements.

          3. Female subjects must be nonpregnant and nonlactating and meet 1 of the following
             criteria:

               1. Postmenopausal (defined as 12 consecutive months with no menses without an
                  alternative medical cause or documented plasma follicle-stimulating hormone level
                  in the postmenopausal range);

               2. Surgically sterile (ie, hysterectomy, bilateral tubal ligation, or bilateral
                  oophorectomy).

                  NOTE: These procedures and laboratory test results must be confirmed by physical
                  examination, or by subject recall of specific date and hospital/facility of
                  procedure, or by medical documentation of said procedure.

               3. Is of childbearing potential (defined as any female who has experienced menarche
                  and who is NOT permanently sterile or postmenopausal), agrees to be
                  heterosexually inactive from at least 21 days prior to enrollment and through 3
                  months after the boosting vaccination or agrees to consistently use any of the
                  following methods of contraception from at least 21 days prior to enrollment and
                  through 3 months after the boosting vaccination:

             i. Condoms (male or female) with spermicide ii. Diaphragm with spermicide iii.
             Cervical cap with spermicide iv. Intrauterine device v. Oral or patch contraceptives
             vi. Norplant®, Depo-Provera®, or other FDA approved contraceptive method that is
             designed to protect against pregnancy.

             NOTE: Periodic abstinence (eg, calendar, ovulation, symptothermal, post ovulation
             methods) and withdrawal are not acceptable methods of contraception.

          4. Has a stable health status as assessed by the investigator, as established by physical
             examination, vital sign measurements, and medical history.

          5. Has access to a consistent and reliable means of telephone contact, which may be in
             the home, workplace, or by personal mobile electronic device.

          6. Is able to understand and comply with planned study procedures.

          7. Lives a reasonable distance from the clinical site to be able to travel to and from
             the clinical site for follow-up visits and agrees to go to the clinical site for
             evaluation (or provide medical record access if evaluated elsewhere) in the event of
             an AE.

          8. Agrees to stay in contact with the clinical site for the duration of the study, has no
             current plans to move from the study area, and provides updated contact information as
             necessary.

        Exclusion Criteria:

          1. History of being vaccinated in the past 5 years against pertussis.

          2. Any significant past reaction to any component of Boostrix (at the discretion of the
             investigator).

          3. Subject reported diagnosis of pertussis in the past 10 years (must be laboratory
             confirmed or physician diagnosed from medical records).

          4. Vital signs by FDA toxicity scoring >1 (may be repeated once during the screening
             period to allow for inclusion and the most recent measurement taken at baseline).

          5. Chronic illness being treated actively and with evidence of recent intervention for
             worsening or fluctuating symptoms (at the discretion of the investigator).

          6. The subject has a history of active cancer (malignancy) in the last 10 years
             (exception is subjects with adequately treated non melanomatous skin carcinoma, who
             may participate in the study).

          7. Current use of any smoking products and unwillingness to refrain from the use of any
             smoking products from screening through 28 days after the boosting vaccination.

          8. Use of narcotic drugs, evidenced by urine toxicology screen or a history of
             drug/alcohol abuse within the past 2 years.

          9. Has donated blood or suffered from blood loss of more than 450 mL (1 unit of blood)
             within 60 days prior to screening or donated plasma within 14 days prior to screening.

         10. Receipt of immunoglobulin, blood-derived products, systemic corticosteroids, or other
             immunosuppressant drugs within 90 days prior to Day 1.

         11. Asthma, obstructive nasal canal, recurrent or acute sinusitis or other chronic
             respiratory problems inclusive of the diagnosis of any significant pulmonary disease.

         12. History of nasal surgery or Bell's palsy.

         13. Use of repeated nasal sprays, Neti pot, routine nasal washing within the past 1 month
             (more than 2 times per week). Subjects must agree to refrain from use of any of these
             modalities through Day 113.

         14. A temporary exclusion to vaccinate if acute respiratory tract infection or rhinorrhea
             or temperature >100.4°F (no symptoms for 3 days prior to vaccination day). Subjects
             may be vaccinated if they stay within the vaccination window (screening [30 days] or
             at the time of the booster [10 days]).

             NOTE: If a subject exceeds the screening window, they must be reconsented and
             screening must be reinitiated.

         15. Use of corticosteroids in the respiratory tract (eg, nasal steroids, inhaled steroids)
             within 30 days prior to Day 1.

         16. Receipt of a licensed vaccine within the last 30 days prior to Day 1 or planned
             vaccination during the active study conduct through Day 113. In the case of seasonal
             influenza, vaccination should not be withheld and is not contraindicated for subject
             participation. However, vaccination should be planned outside of a 30 day pre- and 30
             day post vaccination window whenever possible.

         17. Known hypersensitivity to any component of the study vaccines.

         18. Participation in any other clinical trial for the testing of an unlicensed product
             during the previous 6 months or planned during the study conduct.

         19. Inability to adhere to the protocol, including plans to move from the area.

         20. Personal history or family (first degree) history of congenital or hereditary
             immunodeficiency.

         21. Past or present infection with human immunodeficiency virus, hepatitis B, or hepatitis
             C by screening test.

         22. Any autoimmune or immunodeficiency disease/condition (inherited or iatrogenic).

         23. Any neurological disease or history of significant neurological disorder (eg,
             meningitis, seizures, multiple sclerosis, vasculitis, migraines, Guillain-Barré
             syndrome [genetic/congenital or acquired]).

         24. Any medical condition that, in the opinion of the investigator, might interfere with
             the evaluation of the study objectives or might affect the safety of the individual,
             (eg, major depression or history of suicidal attempt).

         25. Toxicity grading >1 for screening laboratory test results for kidney, hepatic, and
             hematologic values (may be repeated once during the screening period to allow for
             inclusion and the most recent measurement taken at baseline). See Table 13 2 for
             specifically designated parameters.

         26. Body mass index <17 kg/m2 or >40 kg/m2.

         27. Frequent contact with children less than 1 year of age (parent, childcare worker,
             nurse, etc.) or residence in the same household as persons with known immunodeficiency
             including persons on immunosuppressant therapy.

         28. Study team member or first-degree relative of study team member.
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Mary B Manning, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03942406

Organization ID

IB-200P


Responsible Party

Sponsor

Study Sponsor

ILiAD Biotechnologies

Collaborators

 PPD

Study Sponsor

Mary B Manning, MD, Principal Investigator, Rapid Medical Research Inc


Verification Date

July 2020