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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label Adacel | Active Comparator | 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. |
|
| control | No Intervention | Infants born to unvaccinated mothers. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adacel (Tdap) | Drug | Administer Adacel to hiv infected and hiv uninfected pregnant mothers |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Vaccination safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chris Hani Baragwanath Academic Hospital | Johannesburg | GP | 2192 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37773052 | Derived | 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. |
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| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C509326 | adacel |
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open label phase IV clinical trial
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Number of HIV-infected and HIV-uninfected pregnant women with treatment-related adverse events. |
| 24 months |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |