Table 1. A Summary of Trials that Included Women Evaluating Safety and Immunogenicity of HPV Vaccines.
| Authors | Country | HPV Vaccine studied |
Outcome evaluated |
Population studied |
CD4 Cell Count Stratification (N in each stratum) |
Placeb o contro lled |
Outcome | HIV- uninfected control included |
Safety concerns |
|---|---|---|---|---|---|---|---|---|---|
| Palefsky 2014[73] | India | Quadrivalent | Safety and immunogenicity | 150 HIV infected women | Group 1: CD4 nadir ≤ 350, on HAART Group 2: CD4 nadir >350, current CD4 350-500, not on HAART Group 3: CD4 nadir >350, current CD4 >500, not on HAART |
No | Seroconversion rates for HPV types 6, 11, 16, 18: 96%, 97%, 99%, 78% respectively | No | No |
| Kojic 2014[37] | USA, Brazil and South Africa (ACTG) | Quadrivalent | Safety and immunogenicity | 315 HIV infected women aged 13-45 years | Stratum A: CD4 >350 (127 participants) Stratum B: CD4 201-350 (95 participants) Stratum C: CD4 ≤200 (93 participants) |
No | Seroconversion rates for HPV types 6, 11, 16, 18: Stratum A: 96%, 98%, 98%, 91% respectively Stratum B: 100%, 98%, 98%, 84% respectively Stratum C: 84%, 92%, 93%, 75% respectively |
No | No |
| Giacomet, 2014[48] | Italy | Quadrivalent | Safety and immunogenicity | 46 HIV infected and 46 HIV-uninfected males and females aged 13-27 years | No All participants with CD4 ≥350 on HAART |
No | Seroconversion rates: 0.85 in HIV-infected |
Yes Seroconversion rates: 0.91 in HIV-uninfected |
No |
| Toft 2014[74] | Denmark | Quadrivalent and Bivalent | Safety and immunogenicity Of quadrivalent vs. bivalent vaccine | 92 HIV infected men and women 18 years or older | Stratified by use of HAART If on HAART then had a HIV viral load <200 copies Bivalent vaccine: 45 participants Quadrivalent vaccine: 46 participants |
No | GMT endpoints Bivalent induced higher anti-HPV 18 titers than quadrivalent vaccine (GMT ratio 4.31) but no difference found for anti-HPV 16 titers. The bivalent vaccine induced higher HPV 16/18 titers in women than men. No gender difference found for quadrivalent vaccine |
No | No |
| Denny 2013[49] | South Africa | Bivalent | Safety and Immunogenicity | 120 HIV-infected and 30 HIV uninfected females aged 18-25 yea | No HIV viral load or CD4 cell count stratification. Among the 120 HIV infected women, 3 women had a CD4 cell count <200 (2 in vaccine group, 1 in placebo group) | HIV-infected women were placebo controlled | GMT at one month after completing vaccination series (baseline GMT not reported): HPV type 16: 3558 HPV type 18: 1945 Seroprevalence at baseline high among HIV infected, 73% in placebo group and 85% in vaccine recipients. After vaccination, all women seropositive |
GMT at one month after completing vaccination series (baseline GMT not reported): HPV type 16: 8168 HPV type 18: 3703 Seroprevalence at baseline: 63% |
No |
| Kahn 2013[50] | USA and Puerto Rico Adolescent Trials Network (ATN) |
Quadrivalent | Immunogenicity and Safety | 99 HIV-infected and 267 HIV-uninfected women aged 16-23 years | Stratified by Group A: 69 women not on ART for at least 6 months prior to study entry or naïve to treatment Group B: 30 women on antiretroviral therapy (ART) for at least 6 months with HIV RNA plasma loads <400 copes/ml No stratification by CD4 cell count, all participants except one (in group B) had a CD4 count over 200 cells/mm3 |
No | 1. GMT (mMU/ML): Group A: For HPV types 6, 11, 26, 18 titers were 658, 727, 2393, 463 respectively Group B For HPV types 6, 11, 26, 18 titers were 1294, 1522, 5046, 979 respectively 2. Seroconversion rates Group A: For HPV types 6, 11, 26, 18 rates were 100%, 97.1%, 96.4%, 92.3% respectively Group B: Seroconversion rates were 100% for all four HPV types |
1. GMT (mMU/ML) For HPV types 6, 11, 26, 18 titers were 582, 697, 3892, 801 respectively 2. Seroconversion rates were 100% for all four HPV types |
One grade 3 adverse event, fatigue |
| Levin 2010[51] | US and Puerto Rico IMPAACT |
Quadrivalent | Safety and Immunogenicity | 126 HIV-infected children age 7-12 years | Group 1: CD4% nadir < 15 and CD4% ≥ 15 at screening Group 2: CD4% nadir ≥ 15 and CD4% ≥ 15 and <25 at screening Group 3: CD4% nadir ≥25 and CD4% ≥25 at screening |
Yes | Seroconversion rates: Group 1: 100%, 100%, 100%, 90% for HPV types 6, 11, 16, 18 respectively Group 2: 100% for all 4 types Group 3: 100% for all 4 types |
No | No |