PertussisPhase 2WoMANPOWERNCT04589312
Maternal Pertussis Wholecell Responses
A Phase 2 study testing Boostagen, (BioNet-Asia) in people with Pertussis, run by St George's, University of London at 1 site in Uganda.
Trial summary
Pertussis is resurging worldwide. In Africa alone it is estimated that there are 2.1 million cases and 542,000 deaths from pertussis in infants under 1 year with the highest rates of morbidity and mortality in infants <3 months old, before possible prevention via the infant immunization programme1. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- Boostagen, (BioNet-Asia)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteUganda
- Study dates
- 21 Oct 2020to 30 Jun 2023
- Phase
- Phase 2
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be a woman aged 18 years or older, inclusive at day of signing the ICF;
- Pregnant woman at >16 and <26 weeks gestation, verified by ultrasound scan;
- Documented HIV test during pregnancy taken by rapid test at the screening visit;
- Low risk, singleton pregnancy, as assessed by the study physician based on ultrasound scan and previous obstetric history; and
- The woman is willing to comply with the study procedures, including giving birth at Kawempe National Referral Hospital, remaining in the study area until the infant is 1 year old and is able to provide informed consent for herself and on behalf of the infant
Who cannot join
- Any of the following:
- Previous anaphylaxis to any component of Td or Tdap vaccines;
- vaccination is otherwise contraindicated (per product monographs);
- Documented to have received four or more previous tetanus toxoid vaccine doses (as this would prevent randomisation to Tdap group and receipt of two additional tetanus toxoid containing vaccines);
- History of pre-eclampsia or eclampsia in previous pregnancies;
- Gestational diabetes in current pregnancy;
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- Rhesus negative mothers;
- Multigravida;
- Previous late stillbirth (defined as loss of pregnancy at any time after 28 weeks gestation);
- Previous low birth weight baby of less than 2.0 kilograms or premature delivery (defined as a delivery before 37 weeks gestation);
- Previous neonatal death (defined as death of an infant within the first 28 days of life);
- Previous delivery of an infant with a known or suspected genetic or chromosomal abnormality;
- History of other significant pregnancy related complications judged likely to affect the safety of the mother or infant or to significantly compromise the endpoint data collected;
- History of other significant neonatal complications judged likely to affect the safety of the mother or infant or to significantly compromise the endpoint data collected;
- Significant maternal chronic illness including but not limited to hypertension requiring treatment, heart disease, lung disease, neurological disorders including a history of epilepsy or recurrent afebrile seizures, kidney disease, liver disease, anaemia and other haematological disorders (including sickle cell), endocrine disorders including known diabetes mellitus, autoimmunity;
- Severe anaemia (less than 7.0g/dL);
- Known Syphilis or hepatitis B (HBV) virus positive or found to be Syphilis or HBV positive during screening;
- Any other condition judged to significantly increase the risks to either the mother or the infant within the current pregnancy (including relevant history from previous pregnancies);
- Receipt of any blood product including human immunoglobulins at any stage during the current pregnancy or plan to receive any blood products during the period or trial participation (receipt of blood products in an emergency or for obstetric reasons will not represent a protocol deviation given such situations are unplanned);
- Clinically suspected or confirmed congenital or acquired clotting or bleeding disorders or the current receipt of medications known to alter clotting or bleeding;
- Any clinically significant signs or symptoms of acute illness, significant abnormalities in vital signs, an axillary temperature of greater than 38.0°C or any recorded fever (greater than 38.0°C) in the preceding 24 hours;
- Two or more symptoms (nausea/vomiting, diarrhoea, headaches, fatigue and myalgia) rated as grade 2 and clinically significant on the maternal systemic reactogenicity scale present at baseline on the day of vaccination;
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily;
- Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure;
- History of being treated for pertussis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and imMunogeNicity of Combined Pertussis-cOntaining Vaccine (Tdap) for HIV-infected Pregnant WomEn and Their newboRns - A Randomized Clinical Trial
Pertussis is resurging worldwide. In Africa alone it is estimated that there are 2.1 million cases and 542,000 deaths from pertussis in infants under 1 year with the highest rates of morbidity and mortality in infants <3 months old, before possible prevention via the infant immunization programme1. To protect these most vulnerable infants, the World Health Organisation (WHO) recommends Tdap vaccination as safe in pregnancy and recommends the use of wP vaccines within the EPI. Maternal antibody following aP vaccination can interfere with infant anti-pertussis antibody responses post infant EPI vaccination, which is of concern in high burden settings such as Uganda. There are therefore multiple factors in this population which may influence the effect of pertussis immunization in pregnancy, and which have not been studied, most notably HIV infection and interference with wP vaccines in infants. The immunogenicity of Tdap in HIV-infected pregnant women has not yet been examined. In addition, to date, the effect of maternal vaccination, placental transfer and infant antibody responses in HEU infants have not been studied at all. There are no studies examining the immune response to wP vaccine administered to infants (EPI recommendation) whose mothers received aP in pregnancy.
- Conditions
- Pertussis
- Being tested
- Standard of care vaccines, Boostagen, (BioNet-Asia)
- Keywords
- Whooping Cough, Pertussis, Vaccination, Pregnancy, Infant, Newborn, HIV
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care vaccinesBiological
Visit 1: Check tetanus immunisation status. Vaccination up to 25+ 6 weeks of pregnancy with Td; Visit 2: vaccination at least 4 weeks after visit 2 with either Tdap or Td (per randomisation and according to WHO guidance)
Boostagen, (BioNet-Asia)Biological
Visit 1: Check tetanus immunisation status. Vaccination up to 25+ 6 weeks of pregnancy with Td; Visit 2: vaccination at least 4 weeks after visit 2 with either Tdap or Td (per randomisation and according to WHO guidance);
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women not living with HIV, Td vaccine | Active comparator | Not described Receives: Biological: Standard of care vaccines |
| Pregnant women not living with HIV, Tdap vaccine | Experimental | Not described Receives: Biological: Boostagen, (BioNet-Asia) |
| Pregnant women living with HIV, Td vaccine | Active comparator | Not described Receives: Biological: Standard of care vaccines |
| Pregnant women living with HIV, Tdap vaccine | Experimental | Not described Receives: Biological: Boostagen, (BioNet-Asia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-pertussis toxin (PT) and anti-FHA IgG concentrations in cord blood of Tdap-vaccinated HIV-infected vs HIV-uninfected pregnant women.
Measured: At delivery
Anti-pertussis toxin (PT) and anti-FHA IgG concentrations in cord blood of Tdap -vaccinated vs Tdap -unvaccinated pregnant women and whether this differs by maternal HIV status.
Measured: At delivery
Anti-PT and anti-FHA IgG concentrations in infants born to Tdap vaccinated vs Tdap -unvaccinated pregnant women 4 weeks after the completion of a series of primary vaccination with 3 doses of wP vaccine, and whether this differs by maternal HIV status.
Measured: 18 weeks of pregnancy
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Pregnant Women
Percentage of maternal Subjects With Solicited Local and Solicited Systemic AEs and percentage with any Unsolocited AEs; Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal
Measured: First vaccination visits
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Pregnant Women
Percentage of maternal Subjects With Solicited Local and Solicited Systemic AEs and percentage with any Unsolocited AEs; Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal
Measured: At 12 months of age of infants
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Infants
Percentage of Infants With SAEs, Unsolicited AEs and AEs Leading to Study Withdrawal by a clinical examination
Measured: At birth
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Infants
Percentage of Infants With SAEs, Unsolicited AEs and AEs Leading to Study Withdrawal by a clinical examination
Measured: At 18 weeks of age
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Infants
Percentage of Infants With SAEs, Unsolicited AEs and AEs Leading to Study Withdrawal by a clinical examination
Measured: At 6 months of age to assess health of the infant (phone call)
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Infants
Percentage of Infants With SAEs, Unsolicited AEs and AEs Leading to Study Withdrawal by a clinical examination
Measured: At 9 months of age to assess health of the infant (phone call)
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Infants
Percentage of Infants With SAEs, Unsolicited AEs and AEs Leading to Study Withdrawal by a clinical examination
Measured: At 12 months of age to assess health of the infant (phone call)
Secondary outcomes (5)
Anti-PT and anti-FHA IgG concentrations in HIV-infected and HIV-uninfected pregnant women following Tdap vs Td vaccination during pregnancy (4 weeks post-vaccine & at delivery)
Measured: 4 weeks post-vaccine & at delivery
Anti-PT IgG antibody avidity in HIV-infected and HIV-uninfected pregnant women following Tdap vs Td vaccination during pregnancy
Measured: 18 weeks of pregnancy, 4 weeks post-vaccine, at delivery
Serum bactericidal activity in HIV-infected and HIV-uninfected pregnant women following Tdap vs Td vaccination during pregnancy
Measured: 18 weeks of pregnancy, 4 weeks post-vaccine, at delivery
Anti-PT IgG and anti-FHA placental transfer ratios in HIV-infected and HIV-uninfected pregnant women following Tdap vs Td vaccination during pregnancy
Measured: 18 weeks of pregnancy, 4 weeks post-vaccine, at delivery
Tetanus Toxoid antibody responses in HIV-infected and HIV-uninfected pregnant women following Tdap vs Td vaccination during pregnancy
Measured: 18 weeks of pregnancy, 4 weeks post-vaccine, at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start21 Oct 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The study will take a 2x2 formation, with four groups: 1. HIV-uninfected women, standard of care vaccines in pregnancy; 2. HIV-uninfected women, Tdap vaccine in pregnancy; 3. HIV-infected women, standard of care vaccines in pregnancy; 4. HIV-infected women, Tdap vaccine in pregnancy.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, University of British Columbia, Public Health England, MU-JHU CARE, BioNet-Asia
- Responsible party
- Sponsor
- Investigators
- Kirsty Le Doare, MBBS, PhD, Study chair, St George's, University of LondonManish Sadarangani, MRCPCH, DPHIL, BM.BCh, MA, Study chair, BC Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589312
- Sponsor's protocol ID
- 17.0019
- Acronym
- WoMANPOWER
- Status last verified
- Nov 2023
- First submitted
- 1 Oct 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nakabembe E, Greenland M, Amaral K, Abu-Raya B, Amone A, Andrews N, Cantrell L, Lesne E, Gorringe A, Halkerston R, Mcstraw N, Dixon L, Hunter OF, Heath PT, Imede E, Kyohere M, Musoke P, Nakimuli A, Sekikubo M, Taylor S, Tusubira V, Sadarangani M, Le Doare K. Safety and immunogenicity of an acellular pertussis vaccine containing genetically detoxified pertussis toxin administered to pregnant women living with and without HIV and their newborns (WoMANPOWER): a randomised controlled trial in Uganda. Lancet Glob Health. 2025 Jan;13(1):e81-e97. doi: 10.1016/S2214-109X(24)00409-1.
PubMed 39706666
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and imMunogeNicity of Combined Pertussis-cOntaining Vaccine (Tdap) for HIV-infected Pregnant WomEn and Their newboRns - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04589312
- Acronym / sponsor ID
- WoMANPOWER / 17.0019
- Conditions
- Pertussis
- Keywords
- Whooping Cough, Pertussis, Vaccination, Pregnancy, Infant, Newborn, HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Medical Research Council, University of British Columbia, Public Health England, MU-JHU CARE, BioNet-Asia
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pertussis is resurging worldwide. In Africa alone it is estimated that there are 2.1 million cases and 542,000 deaths from pertussis in infants under 1 year with the highest rates of morbidity and mortality in infants <3 months old, before possible prevention via the infant immunization programme1. To protect these most vulnerable infants, the World Health Organisation (WHO) recommends Tdap vaccination as safe in pregnancy and recommends the use of wP vaccines within the EPI. Maternal antibody following aP vaccination can interfere with infant anti-pertussis antibody responses post infant EPI vaccination, which is of concern in high burden settings such as Uganda. There are therefore multiple factors in this population which may influence the effect of pertussis immunization in pregnancy, and which have not been studied, most notably HIV infection and interference with wP vaccines in infants. The immunogenicity of Tdap in HIV-infected pregnant women has not yet been examined. In addition, to date, the effect of maternal vaccination, placental transfer and infant antibody responses in HEU infants have not been studied at all. There are no studies examining the immune response to wP vaccine administered to infants (EPI recommendation) whose mothers received aP in pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The study will take a 2x2 formation, with four groups: 1. HIV-uninfected women, standard of care vaccines in pregnancy; 2. HIV-uninfected women, Tdap vaccine in pregnancy; 3. HIV-infected women, standard of care vaccines in pregnancy; 4. HIV-infected women, Tdap vaccine in pregnancy.
| Arm | Type | Receives |
|---|---|---|
| Pregnant women not living with HIV, Td vaccine | Active comparator | Biological: Standard of care vaccines |
| Pregnant women not living with HIV, Tdap vaccine | Experimental | Biological: Boostagen, (BioNet-Asia) |
| Pregnant women living with HIV, Td vaccine | Active comparator | Biological: Standard of care vaccines |
| Pregnant women living with HIV, Tdap vaccine | Experimental | Biological: Boostagen, (BioNet-Asia) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must be a woman aged 18 years or older, inclusive at day of signing the ICF;
- Pregnant woman at >16 and <26 weeks gestation, verified by ultrasound scan;
- Documented HIV test during pregnancy taken by rapid test at the screening visit;
- Low risk, singleton pregnancy, as assessed by the study physician based on ultrasound scan and previous obstetric history; and
- The woman is willing to comply with the study procedures, including giving birth at Kawempe National Referral Hospital, remaining in the study area until the infant is 1 year old and is able to provide informed consent for herself and on behalf of the infant
Key exclusion criteria (25 listed)
- Previous anaphylaxis to any component of Td or Tdap vaccines;
- vaccination is otherwise contraindicated (per product monographs);
- Documented to have received four or more previous tetanus toxoid vaccine doses (as this would prevent randomisation to Tdap group and receipt of two additional tetanus toxoid containing vaccines);
- History of pre-eclampsia or eclampsia in previous pregnancies;
- Gestational diabetes in current pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care vaccinesVisit 1: Check tetanus immunisation status. Vaccination up to 25+ 6 weeks of pregnancy with Td; Visit 2: vaccination at least 4 weeks after visit 2 with either Tdap or Td (per randomisation and according to WHO guidance) | Biological | Pregnant women living with HIV, Td vaccine, Pregnant women not living with HIV, Td vaccine |
| Boostagen, (BioNet-Asia)Visit 1: Check tetanus immunisation status. Vaccination up to 25+ 6 weeks of pregnancy with Td; Visit 2: vaccination at least 4 weeks after visit 2 with either Tdap or Td (per randomisation and according to WHO guidance); | Biological | Pregnant women living with HIV, Tdap vaccine, Pregnant women not living with HIV, Tdap vaccine |
Primary outcome
Anti-pertussis toxin (PT) and anti-FHA IgG concentrations in cord blood of Tdap-vaccinated HIV-infected vs HIV-uninfected pregnant women.
Time frame: At delivery
Anti-pertussis toxin (PT) and anti-FHA IgG concentrations in cord blood of Tdap -vaccinated vs Tdap -unvaccinated pregnant women and whether this differs by maternal HIV status.
Time frame: At delivery
Anti-PT and anti-FHA IgG concentrations in infants born to Tdap vaccinated vs Tdap -unvaccinated pregnant women 4 weeks after the completion of a series of primary vaccination with 3 doses of wP vaccine, and whether this differs by maternal HIV status.
Time frame: 18 weeks of pregnancy
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Pregnant Women
Time frame: First vaccination visits
Percentage of maternal Subjects With Solicited Local and Solicited Systemic AEs and percentage with any Unsolocited AEs; Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Pregnant Women
Time frame: At 12 months of age of infants
Percentage of maternal Subjects With Solicited Local and Solicited Systemic AEs and percentage with any Unsolocited AEs; Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Infants
Time frame: At birth
Percentage of Infants With SAEs, Unsolicited AEs and AEs Leading to Study Withdrawal by a clinical examination
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Infants
Time frame: At 18 weeks of age
Percentage of Infants With SAEs, Unsolicited AEs and AEs Leading to Study Withdrawal by a clinical examination
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Infants
Time frame: At 6 months of age to assess health of the infant (phone call)
Percentage of Infants With SAEs, Unsolicited AEs and AEs Leading to Study Withdrawal by a clinical examination
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Infants
Time frame: At 9 months of age to assess health of the infant (phone call)
Percentage of Infants With SAEs, Unsolicited AEs and AEs Leading to Study Withdrawal by a clinical examination
Safety Outcome: Safety assessment of Tdap vaccine vs Td vaccine in HIV-infected vs HIV-uninfected pregnant women - Infants
Time frame: At 12 months of age to assess health of the infant (phone call)
Percentage of Infants With SAEs, Unsolicited AEs and AEs Leading to Study Withdrawal by a clinical examination
5 secondary outcomes
Anti-PT and anti-FHA IgG concentrations in HIV-infected and HIV-uninfected pregnant women following Tdap vs Td vaccination during pregnancy (4 weeks post-vaccine & at delivery)
Time frame: 4 weeks post-vaccine & at delivery
Anti-PT IgG antibody avidity in HIV-infected and HIV-uninfected pregnant women following Tdap vs Td vaccination during pregnancy
Time frame: 18 weeks of pregnancy, 4 weeks post-vaccine, at delivery
Serum bactericidal activity in HIV-infected and HIV-uninfected pregnant women following Tdap vs Td vaccination during pregnancy
Time frame: 18 weeks of pregnancy, 4 weeks post-vaccine, at delivery
Anti-PT IgG and anti-FHA placental transfer ratios in HIV-infected and HIV-uninfected pregnant women following Tdap vs Td vaccination during pregnancy
Time frame: 18 weeks of pregnancy, 4 weeks post-vaccine, at delivery
Tetanus Toxoid antibody responses in HIV-infected and HIV-uninfected pregnant women following Tdap vs Td vaccination during pregnancy
Time frame: 18 weeks of pregnancy, 4 weeks post-vaccine, at delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 39706666Nakabembe E, Greenland M, Amaral K, Abu-Raya B, Amone A, Andrews N, Cantrell L, Lesne E, Gorringe A, Halkerston R, Mcstraw N, Dixon L, Hunter OF, Heath PT, Imede E, Kyohere M, Musoke P, Nakimuli A, Sekikubo M, Taylor S, Tusubira V, Sadarangani M, Le Doare K. Safety and immunogenicity of an acellular pertussis vaccine containing genetically detoxified pertussis toxin administered to pregnant women living with and without HIV and their newborns (WoMANPOWER): a randomised controlled trial in Uganda. Lancet Glob Health. 2025 Jan;13(1):e81-e97. doi: 10.1016/S2214-109X(24)00409-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsty Le Doare, MBBS, PhD study chair
St George's, University of London
Manish Sadarangani, MRCPCH, DPHIL, BM.BCh, MA study chair
BC Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Boostagen, (BioNet-Asia) in people with Pertussis, run by St George's, University of London at 1 site in Uganda.
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 5 inclusion and 25 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 22 Nov 2023. 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 Uganda. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Anti-pertussis toxin (PT) and anti-FHA IgG concentrations in cord blood of Tdap-vaccinated HIV-infected vs HIV-uninfected pregnant women. (time frame: At delivery). The study lists 10 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 NCT04589312, 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 22 Nov 2023.