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dTap VaccinePhase 4NCT05264662

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

A Phase 4 study testing Adacel (Tdap) in people with dTap Vaccine, run by Farzanah Laher at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for
dTap Vaccine
What is being tested?
Adacel (Tdap)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
511 participants
Where
1 siteSouth Africa
Study dates
8 Mar 2022to 12 Mar 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Chris Hani Baragwanath Academic Hospital

    Johannesburg, GP, 2192

Other trials in South Africa

About this study

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.

Conditions
dTap Vaccine
Being tested
Adacel (Tdap)
Keywords
Antibodies, Pertussis
Medical subject headings
Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adacel (Tdap)Drug

    Administer Adacel to hiv infected and hiv uninfected pregnant mothers

Study groups in NCT05264662
Study groupRoleWhat they receive
Open label AdacelActive comparatorTdap (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.
Receives: Drug: Adacel (Tdap)
controlNo interventionInfants born to unvaccinated mothers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 months

  2. 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.

    Measured: 24 months

Secondary outcomes (2)

  1. 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.

    Measured: 24 months

  2. Vaccination safety

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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start8 Mar 2022
  3. Primary completion12 Mar 2025
  4. Study completion12 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
open label phase IV clinical trial
Masking
None (open label)
Enrolment
511 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05264662
Sponsor's protocol ID
Maternal Pertussis
Status last verified
May 2026
First submitted
24 Jan 2022
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nunes MC, Tamblyn A, Jose L, Ntsimane M, Lerotholi N, Machimana C, Taylor A, Laher F, Madhi SA. Immunogenicity of tetanus, diphtheria and acellular pertussis vaccination among pregnant women living with and without HIV. AIDS. 2023 Dec 1;37(15):2305-2310. doi: 10.1097/QAD.0000000000003731. Epub 2023 Oct 3.

    PubMed 37773052

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adacel (Tdap) in people with dTap Vaccine, run by Farzanah Laher at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of antibodies in pregnant women 1 month after vaccination with Tdap. (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05264662, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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