Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants

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Brief Title

Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants

Official Title

A Phase II Double-Blind Trial to Evaluate the Safety, Immunogenicity and Effect on Infant Immune Responses of a Single Dose of Tdap in Pregnant Women in Mali

Brief Summary

      This is a phase II, randomized, double-blind, active-controlled study to evaluate the safety,
      immunogenicity, and effect on infant immune responses of a single dose of Tetanus diphtheria
      acellular pertussis vaccine (Tdap) in pregnant women in Mali. 200 healthy pregnant women,
      ages 18 through 39 years, inclusive, who meet all eligibility criteria will be randomly
      allocated in a 2:1 ratio to receive either Tdap (BOOSTRIX) or Tetanus diphtheria toxoid (Td)
      at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA). For the fetuses of
      pregnant subjects, GA will be established by ultrasound, whenever possible, in combination
      with date of last menstrual period (LMP), when available, and fundal height. Study duration
      is 21 months: approximately 2 months in the start-up period, 6 months enrolling subjects, and
      13 months (3-7 months while pregnant and 6 months postpartum) from last subject vaccinated
      until she and her infant complete follow-up. The primary objectives of this study are: 1) to
      assess the safety and tolerability of a single 0.5 mL intramuscular injection of BOOSTRIX in
      pregnant women; 2) to assess the safety of a single maternal BOOSTRIX vaccination on the
      fetus and infant; 3) to assess the level of Pertussis Toxin (PT) antibody at birth among
      infants whose mothers received a single dose of BOOSTRIX or Td while pregnant.
    

Detailed Description

      This is a phase II, randomized, double-blind, active-controlled study to evaluate the safety,
      immunogenicity, and effect on infant immune responses of a single dose of Tetanus diphtheria
      acellular pertussis vaccine (Tdap) in pregnant women in Mali. 200 healthy pregnant women,
      ages 18 through 39 years, inclusive, who meet all eligibility criteria will be randomly
      allocated in a 2:1 ratio to receive either Tdap (BOOSTRIX) or Tetanus diphtheria toxoid (Td)
      at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA). For the fetuses of
      pregnant subjects, GA will be established by ultrasound, whenever possible, in combination
      with date of last menstrual period (LMP), when available, and fundal height. Study duration
      is 21 months: approximately 2 months in the start-up period, 6 months enrolling subjects, and
      13 months (3-7 months while pregnant and 6 months postpartum) from last subject vaccinated
      until she and her infant complete follow-up. The primary objectives of this study are: 1) to
      assess the safety and tolerability of a single 0.5 mL intramuscular injection of BOOSTRIX in
      pregnant women; 2) to assess the safety of a single maternal BOOSTRIX vaccination on the
      fetus and infant; 3) to assess the level of Pertussis Toxin (PT) antibody at birth among
      infants whose mothers received a single dose of BOOSTRIX or Td while pregnant. The secondary
      objectives are: 1) to assess the antibody response to BOOSTRIX vaccine antigens in pregnant
      women one month after receipt of BOOSTRIX, at the time of delivery, and at 6 months after
      delivery; 2) to compare the antibody levels of BOOSTRIX vaccine antigens at birth (cord
      blood) and 6 weeks of age (before receiving any infant doses of Diphtheria, Tetanus, and
      whole-cell Pertussis (DTwP)) in infants whose mothers received BOOSTRIX or Td during
      pregnancy; 3) to assess placental antibody transfer by determining the ratio of maternal and
      infant BOOSTRIX -specific antibody responses at delivery; 4) to assess interference with
      infant antibody responses to DTwP either prior to the second dose of the primary DTwP series,
      at approximately 10 weeks of age (in 1/2 of subjects), or approximately one month after the
      third dose of the primary DTwP series, at approximately 18 weeks of age (in 1/2 of subjects),
      and at 6 months of age (all subjects).
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Frequency of all SAEs in infants of women receiving Tetanus Diphtheria Toxoid (Td) during pregnancy

Secondary Outcome

 GMC of antibodies to DTwP vaccine diphtheria antigens, measured by ELISA among infants whose mothers received intrapartum BOOSTRIX

Condition

Clostridium Difficile Immunisation

Intervention

Tetanus and Diphtheria Toxoids Adsorbed

Study Arms / Comparison Groups

 Group 1
Description:  0.5 ml single dose of Tdap (Tetanus, Diphtheria, Acellular Pertussis Vaccine), BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA).
N=133

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

Biological

Estimated Enrollment

399

Start Date

January 24, 2019

Completion Date

July 1, 2020

Primary Completion Date

July 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Healthy pregnant woman 18-39 years of age, inclusive.

          2. Singleton fetus, with estimated gestational age of 14 0/7 through 26 6/7 weeks
             gestation, inclusive, on the day of study vaccination.

          3. Provide written consent after the nature of the study has been explained according to
             local regulatory requirements and prior to any study procedures*.

             *Prior to obtaining individual informed consent for each subject, the investigators
             will obtain community consent by discussing the trial with all the appropriate local
             groups, as necessary, to obtain permission to approach the subjects. Written, informed
             consent for participation in the trial will be obtained by the investigators from all
             individual subjects. The consent forms will be written in French, the official
             language of Mali, and will be translated into Bambara, the most prevalent of the local
             languages, and recorded on audiotape.

          4. In good health as determined by medical history, targeted physical examination*
             (physical examination performed as part of routine antenatal care of a study-specific
             brief exam may be used to determine eligibility), vital signs (oral temperature < 37.8
             degrees Celsius; pulse 55 to 100 beats per minute (bpm), inclusive; systolic blood
             pressure 90 to 140 millimeters of mercury (mm Hg), inclusive; diastolic blood pressure
             55 to 90 mm Hg, inclusive), and clinical judgment of the investigator.

             *If indicated based on medical history, to evaluate acute or currently ongoing chronic
             medical diagnoses or conditions that would affect the assessment of eligibility and
             safety of subjects. Chronic medical diagnoses or conditions being actively managed
             must be within acceptable limits in the last 180 days. Any prescription change that is
             due to change of health care provider, insurance company, etc., or that is done for
             financial reasons, as long as in the same class of medication, will not be considered
             a deviation of this inclusion criterion. Any change in prescription medication due to
             improvement of a disease outcome, as determined by the site principal investigator or
             appropriate sub-investigator, will not be considered a deviation of this inclusion
             criterion. Subjects may be on chronic or as needed (prn) medications if, in the
             opinion of the site principal investigator or appropriate sub-investigator, they pose
             no additional risk to subject safety or assessment of reactogenicity and
             immunogenicity and do not indicate a worsening of medical diagnosis or condition.
             Similarly, medication changes subsequent to enrollment and the study vaccination are
             acceptable provided the subject is asymptomatic, condition stable, and there is no
             additional risk to the subject or interference with the evaluation of responses to the
             study vaccination.

          5. Ability to comprehend and comply with all study procedures, as determined by the
             investigator determining eligibility, and availability for follow-up.

          6. Willing to allow study staff to gather pertinent medical information, including
             pregnancy outcome data and medical information about her infant.

        Exclusion Criteria:

          1. History of illness or an ongoing illness that, in the opinion of the investigator, may
             pose additional risk to the subject or her fetus if she participates in the study.

          2. Infection requiring systemic antibiotics or antiviral treatment within the 7 days
             prior to study vaccination.

          3. Fever (oral temperature > / = 37.8 degrees Celsius/100.0 degrees Fahrenheit) or other
             acute illness within 3 days prior to study vaccination*.

             *An acute illness which is nearly resolved with only minor residual symptoms remaining
             is allowable if, in the opinion of the site principal investigator or appropriate
             sub-investigator, the residual symptoms will not interfere with the ability to assess
             safety parameters as required by the protocol.

          4. Known active neoplastic disease (excluding non-melanoma skin cancer), anticancer
             chemotherapy, or radiation therapy (cytotoxic) within 3 years prior to study
             vaccination.

          5. History of any hematologic malignancy at any time.

          6. A history of a serious adverse event following previous immunizations (e.g., Bell's
             Palsy, Guillain-Barre Syndrome, encephalopathy), or history of progressive neurologic
             disorders.

          7. Known or suspected disease that impairs the immune system including known or suspected
             HIV infection or HIV-related disease.

          8. Receipt of immunosuppressive therapy, including long-term use of glucocorticoids:
             oral, inhaled, intranasal or parenteral prednisone > / = 20 mg/day or equivalent for
             more than 2 weeks within the 30 days prior to enrollment. Use of topical
             corticosteroids is allowed.

          9. Known hepatitis B or hepatitis C infection, by history or medical record.

         10. Behavioral or cognitive impairment or psychiatric disease (includes hospitalization
             for psychiatric illness, suicide attempt, or confinement for danger to self or others
             within 10 years prior to study vaccination) that, in the opinion of the investigator,
             may interfere with the subject's ability to participate in the trial.

         11. Have a history of alcohol or drug abuse within 5 years prior to study vaccination
             (that is believed by the site investigator to potentially interfere with the subject's
             ability to participate in the study).

         12. Known hypersensitivity or allergy to any component of the study vaccine (formaldehyde,
             alum).

         13. History of severe allergic reaction (e.g., anaphylaxis) after a previous dose of
             BOOSTRIX or any other vaccine directed against tetanus, diphtheria, or pertussis.

         14. Receipt or planned receipt of any live licensed vaccine within 30 days before or after
             vaccination or any inactivated licensed vaccine within 14 days before or after
             vaccination.

         15. Receipt of immunoglobulin (except RhoGAM, which is allowed) or other blood products
             within 90 days prior to study vaccination.

         16. Receipt of an experimental agent or device within 30 days prior to vaccination, or the
             expected receipt of an experimental agent* (other than BOOSTRIX) during this
             trial-reporting period.

             *Experimental agents include vaccines, drugs, biologics, devices, blood products, and
             medications. Subjects who have received a licensed product, as a subject in a clinical
             trial, within 30 days prior to vaccination or who are expecting to enroll in such a
             trial during the study period will also be excluded. Observational studies, surveys,
             and other studies that do not involve experimental agents or devices are allowed.

         17. High risk for serious obstetrical complication (refer to ACOG Practice Bulletins for
             definitions, as necessary)*.

             *Including the following: (a) gestational hypertension (well controlled history of
             essential or gestational hypertension, as evidenced by normal BPs as defined above, is
             allowed), (b) gestational diabetes not controlled by diet and exercise (the use of
             insulin or glyburide to control gDM, at the time of enrollment, is exclusionary), (c)
             current pre-eclampsia or eclampsia, (d) known current multiple gestation, (e)history
             of preterm delivery before EGA 35 weeks 0 days or current preterm labor, and/or (f)
             known intrauterine fetal growth restriction (defined as ultrasound confirmation of an
             estimated fetal weight that is less than the 10th percentile for gestational age).

         18. Pregnant with a fetus with a known or suspected major congenital anomaly or genetic
             abnormality.

         19. Study personnel or immediate family members (brother, sister, child, parent) or the
             spouse of study personnel.
      

Gender

Female

Ages

18 Years - 39 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

Mali

Location Countries

Mali

Administrative Informations


NCT ID

NCT03589768

Organization ID

16-0024

Secondary IDs

HHSN272201300022I

Responsible Party

Sponsor

Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)


Study Sponsor

, , 


Verification Date

October 4, 2018