Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine in HIV-positive women in South Africa: A partially-blind randomised placebo-controlled study

Abstract

In developing countries, risk of human papillomavirus (HPV) infection may be increased by the high prevalence of human immunodeficiency virus (HIV) infection. We evaluated the safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine in HIV-infected women in South Africa. Asymptomatic HIV-positive women aged 18-25 years (N=120) were stratified by CD4⁺ T-cell count and randomised (1:1) to receive HPV-16/18 vaccine (Cervarix®; GlaxoSmithKline Vaccines) or placebo (Al[OH]3) at 0, 1 and 6 months (double-blind). HIV-negative women (N=30) received HPV-16/18 vaccine (open label). Anti-HPV-16/18 antibody and CD4⁺ T-cell responses, CD4⁺ T-cell count, HIV viral load, HIV clinical stage and safety were evaluated for 12 months. The safety and reactogenicity profile of the HPV-16/18 vaccine was comparable in HIV-positive and HIV-negative women. Irrespective of baseline HPV status, all HIV-positive and HIV-negative women who received the HPV-16/18 vaccine were seropositive for both HPV-16 and HPV-18 after the second vaccine dose (month 2) and remained seropositive for both antigens at month 12. Anti-HPV-16/18 antibody titres at month 12 remained substantially above levels associated with natural infection. The HPV-16/18 vaccine induced sustained anti-HPV-16/18 CD4⁺ T-cell responses in both HIV-positive and HIV-negative women. No impact of baseline CD4⁺ T-cell count or HIV viral load was observed on the magnitude of the immune response in HIV-positive women. In HIV-positive women, CD4⁺ T-cell count, HIV viral load and HIV clinical stage were unaffected by HPV-16/18 vaccine administration. In conclusion, the HPV-16/18 AS04-adjuvanted vaccine appears immunogenic and well-tolerated in women with HIV infection. Study ID: 107863/NCT00586339.

Vaccination against oncogenic human papillomavirus infection in HIV-infected populations: review of current status and future perspectives

“…Denny et al 34 recently published data from a partially blinded, placebo-controlled trial investigating the safety and immunogenicity of the bivalent HPV vaccine in young women. HIV-positive women (n = 120) aged 18-25 years were assigned to receive the bivalent vaccine or a placebo in a standard regimen with vaccinations at 0, 1 and 6 months.…”

“…Recent data from immunocompetent young women suggest that two doses, or even one dose, of the bivalent HPV vaccine, could be as efficacious as three doses in protecting against persistent HPV-16 and -18 infections. 42 Convincing immunogenicity data are available for young HIV-infected women aged 18-25 years for the bivalent vaccine 34 and HIV-infected women aged 16-23 years for the quadrivalent vaccine. 33 High seroconversion rates were observed for both vaccines.…”

Processing of blood samples influences PBMC viability and outcome of cell-mediated immune responses in antiretroviral therapy-naïve HIV-1-infected patients

“…By compiling previous evaluations, we observed a lower PBMC viability after ICS in antiretroviral therapy (ART)-naïve HIV-1-infected patients (ART − HIV + ) compared to ART-experienced HIV-1-infected patients (ART + HIV + ) (samples from trial published in Harrer et al, 2014) or uninfected volunteers (HIV − ) (samples from trial published in Denny et al, 2013) (Fig. 1).…”

Immunization of HIV-infected adult patients — French recommendations

“…No information exists regarding protection against persistent infection or precancerous lesions in HIV-infected women. 87 The high HPV infection rate and associated mucosal lesions are good reasons to recommend HPV vaccination in HIVinfected patients.…”