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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
181
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)
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);
MUJHU Care Ltd
Kampala, Uganda
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 12 months of age to assess health of the infant (phone call)
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
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