- |||||||||| ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Clinical, Journal: Non-HIV Vaccine-Induced Immune Responses as Potential Baseline Immunogenicity Predictors of ALVAC-HIV and AIDSVAX B/E-Induced Immune Responses. (Pubmed Central) - Sep 29, 2024
The fourth significant correlation [(rho = 0.361; 95% CI: 0.049, 0.609; p = 0.021; FDR = 0.137)] was between CD4+ T-cell responses to a hepatitis B surface antigen peptide pool, measured 2 weeks after the third HBV vaccination, and IgG-binding antibody responses to gp70BCaseAV1V2 (B V1V2 immune correlate), measured two weeks after the second ALVAC-HIV and AIDSVAX B/E boost. These moderate correlations imply that either vaccine, TT or HBV, could potentially provide a moderately useful immunogenicity predictor for the ALVAC-HIV and AIDSVAX B/E HIV vaccine regimen.
- |||||||||| ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Sex-specific immune responses to ALVAC-HIV and bivalent subtype C gp120/MF59 in the HVTN 100 clinical trial in South Africa (Poster Exhibition) - Aug 9, 2024 - Abstract #HIVR4P2024HIVR4P_863;
We found selected differences in immune responses by sex assigned at birth for the HVTN 100 vaccine regimen; however, these varied by immune response type. Although this regimen proved inefficacious regardless of sex-assigned-at-birth, future HIV vaccine trials should investigate whether there are sex-specific differences in immunogenicity and efficacy.
- |||||||||| ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
The vaginal microbiome pre-vaccination associates with local and systemic HIV vaccine immune responses (Cusco Ballroom/Channel 4) - Aug 9, 2024 - Abstract #HIVR4P2024HIVR4P_142;
These data suggest an association between the vaginal microbiome and vaccine-induced BAb responses, with a more inflammatory polymicrobial environment being associated with lower vaccine-specific BAb levels. These results warrant further interrogations into the potential mechanisms by which the vaginal microbiome may impact vaccine responses and could inform interventional strategies.
- |||||||||| Potential novel vaccine adjuvant to enhance ADCC-mediated NK cells in the HIV preventive vaccines (Poster board: 030) - May 2, 2024 - Abstract #AIDS2024AIDS_1075;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- |||||||||| HIV vaccine vCP2438 / Sanofi, GSK, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Safety and Immunogenicity of Month 30 Boost of ALVAC+gp120/MF59 Preventive HIV Vaccines (Poster hall) - Mar 5, 2024 - Abstract #CROI2024CROI_176;
Booster vaccination with gp120/MF59 given alone or with ALVAC after an 18-month interval was safe and induced binding, tier 1A neutralization and CD4+ T-cell responses similarly in both vaccine groups. Late boosting may increase breadth of responses and restore V1V2 binding antibody responses.
- |||||||||| ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Journal, Viral vector: Viral vector delivered immunogen focuses HIV-1 antibody specificity and increases durability of the circulating antibody recall response. (Pubmed Central) - May 31, 2023
P1, P1/2,
The RV305 HIV-1 clinical trial evaluated the immunological impact of a follow-up boost of HIV-1-uninfected RV144 recipients after 6-8 years with RV144 immunogens (ALVAC-HIV alone, AIDSVAX B/E gp120 alone, or ALVAC-HIV + AIDSVAX B/E gp120)...Trial registration: RV305 clinical trial (ClinicalTrials.gov number, NCT01435135). ClinicalTrials.gov Identifier: NCT00223080, ClinicalTrials.gov Identifier: NCT01931358, ClinicalTrials.gov Identifier: NCT01923610, ClinicalTrials.gov Identifier: NCT01461447.
- |||||||||| ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Journal: ALVAC-HIV and AIDSVAX B/E vaccination induce improved immune responses compared with AIDSVAX B/E vaccination alone. (Pubmed Central) - May 12, 2023
Lastly, levels of the Fc-mediated effector functions antibody-dependent cellular cytotoxicity, NK cell activation, and trogocytosis were significantly increased in participants who received ALVAC-HIV compared with those receiving AIDSVAX B/E alone. Taken together, these results suggest that ALVAC-HIV plays an essential role in developing cellular and humoral immune responses to protein-boosted regimens relative to protein alone.
- |||||||||| HIV vaccine vCP1521 / Sanofi, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial completion date, Trial primary completion date: Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX (clinicaltrials.gov) - Apr 22, 2021
P2, N=360, Active, not recruiting,
Taken together, these results suggest that ALVAC-HIV plays an essential role in developing cellular and humoral immune responses to protein-boosted regimens relative to protein alone. Trial completion date: May 2021 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial completion date, Trial primary completion date: Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59 (clinicaltrials.gov) - Jan 8, 2021
P1/2, N=160, Completed,
Trial completion date: May 2021 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021 Trial completion date: Oct 2019 --> Jul 2020 | Trial primary completion date: Oct 2019 --> Jul 2020
- |||||||||| HIV vaccine vCP1521 / Sanofi, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial completion date, Trial primary completion date: Study of Late Boost Strategies for HIV-uninfected Participants From Protocol RV 144 (clinicaltrials.gov) - Nov 3, 2020
P2, N=162, Active, not recruiting,
Trial completion date: Oct 2019 --> Jul 2020 | Trial primary completion date: Oct 2019 --> Jul 2020 Trial completion date: Dec 2020 --> Jul 2021 | Trial primary completion date: Jul 2020 --> Jul 2021
- |||||||||| HIV vaccine vCP1521 / Sanofi, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial completion date, Trial primary completion date: Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX (clinicaltrials.gov) - Mar 10, 2020
P2, N=360, Active, not recruiting,
Trial completion date: Dec 2020 --> Jul 2021 | Trial primary completion date: Jul 2020 --> Jul 2021 Trial completion date: May 2020 --> May 2021 | Trial primary completion date: Dec 2019 --> Dec 2020
- |||||||||| ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial completion: Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59 (clinicaltrials.gov) - Nov 8, 2019
P1/2, N=160, Completed,
Trial completion date: May 2020 --> May 2021 | Trial primary completion date: Dec 2019 --> Dec 2020 Active, not recruiting --> Completed
- |||||||||| HIV vaccine vCP1521 / Sanofi, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial completion date, Trial primary completion date: Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX (clinicaltrials.gov) - Sep 23, 2019
P2, N=360, Active, not recruiting,
Active, not recruiting --> Completed Trial completion date: Dec 2019 --> May 2020 | Trial primary completion date: Jul 2019 --> Dec 2019
- |||||||||| HIV vaccine vCP1521 / Sanofi, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial completion date, Trial primary completion date: Study of Late Boost Strategies for HIV-uninfected Participants From Protocol RV 144 (clinicaltrials.gov) - Sep 18, 2019
P2, N=162, Active, not recruiting,
Trial completion date: Dec 2019 --> May 2020 | Trial primary completion date: Jul 2019 --> Dec 2019 Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Jul 2019 --> Jul 2020
- |||||||||| HIV vaccine vCP1521 / Sanofi, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial completion, Phase classification, Enrollment change: HVTN 097: Safety of and Immune Response to Vaccination With 2 Experimental HIV Vaccines in Healthy Adults (clinicaltrials.gov) - Jun 21, 2019
P1b, N=202, Completed,
Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Jul 2019 --> Jul 2020 Active, not recruiting --> Completed | Phase classification: P1 --> P1b | N=100 --> 202
- |||||||||| ALVAC-HIV (vCP2438)/Bivalent Subtype C gp120/MF59 / National Institute of Allergy and Infectious Diseases, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial completion, Trial completion date, Trial primary completion date: A Safety and Immune Response Study of 2 Experimental HIV Vaccines (clinicaltrials.gov) - Apr 22, 2019
P1/2, N=252, Completed,
Active, not recruiting --> Completed | Phase classification: P1 --> P1b | N=100 --> 202 Active, not recruiting --> Completed | Trial completion date: Jan 2017 --> Aug 2018 | Trial primary completion date: Jan 2017 --> Aug 2018
- |||||||||| ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Enrollment closed: Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59 (clinicaltrials.gov) - Oct 22, 2018
P1/2, N=160, Active, not recruiting,
Active, not recruiting --> Completed | Trial completion date: Jan 2017 --> Aug 2018 | Trial primary completion date: Jan 2017 --> Aug 2018 Recruiting --> Active, not recruiting
- |||||||||| HIV vaccine vCP1521 / Sanofi, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial completion date, Trial primary completion date: Study of Late Boost Strategies for HIV-uninfected Participants From Protocol RV 144 (clinicaltrials.gov) - May 3, 2018
P2, N=162, Active, not recruiting,
Active, not recruiting --> Completed Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2017 --> Dec 2018
- |||||||||| HIV vaccine vCP1521 / Sanofi, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial completion date, Trial primary completion date: Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX (clinicaltrials.gov) - May 3, 2018
P2, N=360, Active, not recruiting,
Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2017 --> Dec 2018 Trial completion date: Apr 2018 --> Oct 2018 | Trial primary completion date: Mar 2018 --> Sep 2018
- |||||||||| ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Enrollment open: Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59 (clinicaltrials.gov) - Jan 23, 2018
P1/2, N=320, Recruiting,
Trial completion date: Apr 2018 --> Oct 2018 | Trial primary completion date: Mar 2018 --> Sep 2018 Not yet recruiting --> Recruiting
- |||||||||| HIV vaccine vCP1521 / Sanofi, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial primary completion date: Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX (clinicaltrials.gov) - Jan 16, 2018
P2, N=360, Active, not recruiting,
Not yet recruiting --> Recruiting Trial primary completion date: Nov 2017 --> Mar 2018
- |||||||||| ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial initiation date, Trial primary completion date: Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59 (clinicaltrials.gov) - Nov 13, 2017
P1/2, N=320, Not yet recruiting,
Trial primary completion date: Nov 2017 --> Mar 2018 Initiation date: Jun 2017 --> Dec 2017 | Trial primary completion date: Dec 2018 --> Sep 2019
- |||||||||| HIV vaccine vCP1521 / Sanofi, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial primary completion date: Study of Late Boost Strategies for HIV-uninfected Participants From Protocol RV 144 (clinicaltrials.gov) - Mar 29, 2017
P2, N=162, Active, not recruiting,
Initiation date: Jun 2017 --> Dec 2017 | Trial primary completion date: Dec 2018 --> Sep 2019 Trial primary completion date: Dec 2016 --> Dec 2017
- |||||||||| HIV vaccine vCP1521 / Sanofi, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Trial primary completion date: Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX (clinicaltrials.gov) - Mar 29, 2017
P2, N=360, Active, not recruiting,
Trial primary completion date: Dec 2016 --> Dec 2017 Trial primary completion date: Nov 2016 --> Nov 2017
- |||||||||| ALVAC-HIV (vCP2438)/Bivalent Subtype C gp120/MF59 / National Institute of Allergy and Infectious Diseases, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Enrollment closed: A Safety and Immune Response Study of 2 Experimental HIV Vaccines (clinicaltrials.gov) - Dec 11, 2015
P1/2, N=252, Active, not recruiting,
Suspended --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| ALVAC-HIV (vCP2438)/Bivalent Subtype C gp120/MF59 / National Institute of Allergy and Infectious Diseases, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
New P1/2 trial, New P2 trial: A Safety and Immune Response Study of 2 Experimental HIV Vaccines (clinicaltrials.gov) - Mar 31, 2015
P1/2, N=252, Recruiting,
- |||||||||| HIV vaccine vCP1521 / Sanofi, ALVAC-HIV / National Institute of Allergy and Infectious Diseases, Sanofi
Enrollment open, Trial primary completion date: Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX (clinicaltrials.gov) - Jul 15, 2014
P2, N=360, Recruiting,
Active, not recruiting --> Completed Not yet recruiting --> Recruiting | Trial primary completion date: Aug 2015 --> Nov 2016
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