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Pertussis Vaccination Among HIV-infected and HIV-uninfected Pregnant Women

Primary Purpose

dTap Vaccine

Status

Not yet recruiting

Phase

Phase 4

Locations

South Africa

Study Type

Interventional

Intervention

Adacel (Tdap)

About this trial

This is an interventional treatment trial for dTap Vaccine focused on measuring Antibodies, Pertussis

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Pregnant women age ≥18 years to <39 years (vaccinated group only).
Gestational age 20-36 weeks documented by the approximate date of the last menstrual period and corroborated by physical or sonargraphic exam (vaccinated group only).
Documented to be HIV-infected or HIV-uninfected.
Good general maternal health.
Able to understand and comply with planned study procedures.
Able and willing to provide written informed consent for themselves and infant

Exclusion Criteria:

Receipt of any live licensed vaccine ≤14 days prior to study initiation.
Any significant (in the opinion of the site investigator) acute illness.
Use of anti-cancer systemic chemotherapy or radiation therapy ≤48 weeks of study enrolment or has immunosuppression as a result of an underlying illness or treatment.
Long term use of glucocorticoids, including oral or parenteral prednisone ≥20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) ≤12 weeks of study entry, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) ≤12 weeks before study entry (nasal and topical steroids are allowed).
Receipt of corticosteroids for preterm labour ≤14 days before study entry.
Receipt of immunoglobulin or other blood products (with exception of Rho D immune globulin) ≤12 weeks prior to enrolment in this study or is scheduled to receive immunoglobulin or other blood products (with the exception of Rho D immune globulin) during pregnancy or for the first 24 weeks after delivery.
Receipt of IL2, IFN, GMCSF or other immune mediators ≤12 weeks before enrolment.
Uncontrolled major psychiatric disorder.
History of a severe adverse reaction to previous vaccines (vaccinated group only).
Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Pregnancy complications (in the current pregnancy) such as pre-term labour, hypertension (BP >140/90 in the presence of proteinuria or BP >150/100, with or without proteinuria or currently on antihypertensive medication) and pre-eclampsia.

Sites / Locations

Chris Hani Baragwanath Academic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Open label Adacel

control

Arm Description

Tdap (Adacel) ADACEL (0,5 ml) should be administered as an injection by the intramuscular route. Re-dosing with ADACEL can be used to boost immunity to diphtheria, tetanus and pertussis at 5- to 10-year intervals. ADACEL may be administered to pregnant women during the second and third trimester to provide passive protection to infants against pertussis.

Infants born to unvaccinated mothers.

Outcomes

Primary Outcome Measures

Concentration of antibodies in pregnant women 1 month after vaccination with Tdap.

To measure antibody responses to all Tdap-IPV antigens (diphtheria, tetanus, PT, FHA, PRN, FIM and polioviruses 1, 2 and 3) in HIV-infected compared with HIV-uninfected pregnant women before and one month after Adacel vaccination.

Concentration of antibodies to all Tdap-IPV and Hexavalent antigens in infants.

To measure antibody responses to all Tdap-IPV and Hexavalent antigens (diphtheria, tetanus, PT, FHA, PRN, FIM, Haemophilus influenzae type-b polyribosyl ribitol phosphate [PRP], polioviruses 1, 2 and 3, and hepatitis B) testing in infants born to mothers who received Adacel during pregnancy and those born to mothers not vaccinated, stratified by maternal HIV status.

Secondary Outcome Measures

Transplacental antibody transfer.

To compare the transplacental antibody transfer ratio of all Tdap-IPV antigens to newborns from HIV-infected mothers and those born to HIV-uninfected mothers vaccinated with Adacel during pregnancy.

Vaccination safety

Number of HIV-infected and HIV-uninfected pregnant women with treatment-related adverse events.

Full Information

NCT ID

NCT05264662

First Posted

January 24, 2022

Last Updated

March 2, 2022

Sponsor

Shabir Madhi

1. Study Identification

Unique Protocol Identification Number

NCT05264662

Brief Title

Pertussis Vaccination Among HIV-infected and HIV-uninfected Pregnant Women

Official Title

Pertussis Vaccination Among HIV-infected and HIV-uninfected Pregnant Women

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 2022 (Anticipated)

Primary Completion Date

May 2025 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shabir Madhi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Pertussis (also known as whooping cough) is a highly contagious, vaccine-preventable respiratory tract disease, caused by the bacteria Bordetella pertussis. It can affect people of all ages, however young unimmunised or partially immunised infants are the most vulnerable group with the highest rates of complications and death. Recent surveillance data and an increase in the number of pertussis outbreaks being reported nationally, indicate an increase in the incidence of pertussis disease in South Africa.To date there is no data on the effect of vaccinating HIV-infected pregnant women with pertussis-containing vaccines, although there is no reason to think that vaccinating these women would be harmful for them or their foetus. The knowledge gaps on the immunogenicity, safety and VE of pertussis vaccination of HIV-infected pregnant women should be addressed. Adacel which is a registered and licensed vaccine manufactured by Sanofi Pasteur, will be tested in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

dTap Vaccine

Keywords

Antibodies, Pertussis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

open label phase IV clinical trial

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Open label Adacel

Arm Type

Active Comparator

Arm Description

Arm Title

control

Arm Type

No Intervention

Arm Description

Infants born to unvaccinated mothers.

Intervention Type

Drug

Intervention Name(s)

Adacel (Tdap)

Intervention Description

Administer Adacel to hiv infected and hiv uninfected pregnant mothers

Primary Outcome Measure Information:

Title

Concentration of antibodies in pregnant women 1 month after vaccination with Tdap.

Description

Time Frame

24 months

Title

Concentration of antibodies to all Tdap-IPV and Hexavalent antigens in infants.

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Transplacental antibody transfer.

Description

To compare the transplacental antibody transfer ratio of all Tdap-IPV antigens to newborns from HIV-infected mothers and those born to HIV-uninfected mothers vaccinated with Adacel during pregnancy.

Time Frame

24 months

Title

Vaccination safety

Description

Number of HIV-infected and HIV-uninfected pregnant women with treatment-related adverse events.

Time Frame

24 months

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pregnant women age ≥18 years to <39 years (vaccinated group only). Gestational age 20-36 weeks documented by the approximate date of the last menstrual period and corroborated by physical or sonargraphic exam (vaccinated group only). Documented to be HIV-infected or HIV-uninfected. Good general maternal health. Able to understand and comply with planned study procedures. Able and willing to provide written informed consent for themselves and infant Exclusion Criteria: Receipt of any live licensed vaccine ≤14 days prior to study initiation. Any significant (in the opinion of the site investigator) acute illness. Use of anti-cancer systemic chemotherapy or radiation therapy ≤48 weeks of study enrolment or has immunosuppression as a result of an underlying illness or treatment. Long term use of glucocorticoids, including oral or parenteral prednisone ≥20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) ≤12 weeks of study entry, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) ≤12 weeks before study entry (nasal and topical steroids are allowed). Receipt of corticosteroids for preterm labour ≤14 days before study entry. Receipt of immunoglobulin or other blood products (with exception of Rho D immune globulin) ≤12 weeks prior to enrolment in this study or is scheduled to receive immunoglobulin or other blood products (with the exception of Rho D immune globulin) during pregnancy or for the first 24 weeks after delivery. Receipt of IL2, IFN, GMCSF or other immune mediators ≤12 weeks before enrolment. Uncontrolled major psychiatric disorder. History of a severe adverse reaction to previous vaccines (vaccinated group only). Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. Pregnancy complications (in the current pregnancy) such as pre-term labour, hypertension (BP >140/90 in the presence of proteinuria or BP >150/100, with or without proteinuria or currently on antihypertensive medication) and pre-eclampsia.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marta Nunes, PhD

Phone

+27119834283

marta.nunes@wits-vida.org

Facility Information:

Facility Name

Chris Hani Baragwanath Academic Hospital

City

Johannesburg

State/Province

ZIP/Postal Code

2192

Country

South Africa

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pertussis Vaccination Among HIV-infected and HIV-uninfected Pregnant Women

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