Trial Outcomes & Findings for Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults (NCT NCT02919306)
NCT ID: NCT02919306
Last Updated: 2025-02-04
Results Overview
Solicited local AE of grade 3 or 4 and that is thought to be related to study vaccine were reported. An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (at injection site) included pain/tenderness, erythema, induration, swelling, itching and warmth were collected and reported for 7 days after each vaccination.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Up to Week 49 (7 days post each vaccination)
Results posted on
2025-02-04
Participant Flow
Of the 37 participants screened for this study, 27 participants were randomized and received at least 1 dose of active vaccine (18 participants) or placebo (9 participants). One participant in the active vaccine group was excluded from the analysis on request of the Ethics Committee due to a major protocol deviation.
Participant milestones
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
9
|
|
Overall Study
COMPLETED
|
16
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults
Baseline characteristics by cohort
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.4 years
STANDARD_DEVIATION 5.39 • n=5 Participants
|
26.3 years
STANDARD_DEVIATION 6.87 • n=7 Participants
|
27 years
STANDARD_DEVIATION 5.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
THAILAND
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 49 (7 days post each vaccination)Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
Solicited local AE of grade 3 or 4 and that is thought to be related to study vaccine were reported. An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (at injection site) included pain/tenderness, erythema, induration, swelling, itching and warmth were collected and reported for 7 days after each vaccination.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With Grade 3 or 4 Solicited Local Adverse Events (AEs)
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 49 (7 days post each vaccination)Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
Solicited systemic AE of grade 3 or 4 and that is thought to be related to study vaccine were reported. Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With Grade 3 or 4 Solicited Systemic AEs
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 52 (28 days after each vaccination)Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
Unsolicited AE with worst severity grade 3 or 4 and that is thought to be related to study vaccine were reported. Unsolicited AEs were defined as events that participants experienced but were not specifically asked about.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With Grade 3 or 4 Unsolicited AEs
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 52 (28 days after each vaccination)Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
Related AEs of grade 3 or 4 and that is thought to be related to study vaccine were reported.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With Grade 3 or 4 Related AEs
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 49 (7 days post each vaccination)Population: The Full Analysis Set (FAS) included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (at injection site) included pain/tenderness, erythema, induration, swelling, itching and warmth were collected and reported for 7 days after each vaccination.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With Solicited Local AEs for 7 Days After Each Vaccination
|
88.2 percentage of participants
|
66.7 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 49 (7 days after each vaccination)Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching were collected and reported for 7 days after each vaccination.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs for 7 Days After Each Vaccination
|
70.6 percentage of participants
|
55.6 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 52 (28 days after each vaccination)Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
Unsolicited AEs were defined as events that participants experienced but were not specifically asked about.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With Unsolicited AEs 28 Days After Each Vaccination
|
88.2 percentage of participants
|
77.8 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 52 (28 days after each vaccination)Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With Related AEs and Serious Adverse Events (SAEs)
Related AEs
|
29.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Related AEs and Serious Adverse Events (SAEs)
Related SAEs
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 96Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
Percentage of participants with AEs leading to discontinuation of study vaccination were reported.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With AEs Leading to Discontinuation of Study Vaccination
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 52 (28 days after each vaccination)Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo. The data was planned for unsolicited AEs during the 28-day post-vaccination phase.
Percentage of participants with AEs were reported.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With AEs
|
88.2 percentage of participants
|
77.8 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 96Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories.
Percentage of participants with worst laboratory grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening) and non-graded serum chemistry abnormalities were reported. Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, creatine, hyperglycemia, hypoglycemia, gamma-gutamyl transferase, chloride, urea nitrogen, and bilirubin. The parameters not represented in the grading scale, abnormalities were indicated as being 'high' or 'low' or 'abnormal'.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
Post-Any Dose: Alanine Aminotransferase- Grade 1
|
50 percentage of participants
|
—
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
Post-Any Dose: Alanine Aminotransferase- Grade 3
|
50 percentage of participants
|
—
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
Post-Any Dose: Aspartate Aminotransferase- Grade 1
|
50 percentage of participants
|
—
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
Post-Any Dose: Aspartate Aminotransferase- Grade 4
|
50 percentage of participants
|
—
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
ART resumption: Alanine Aminotransferase- Grade 1
|
12.5 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
ART resumption: Aspartate Aminotransferase- Grade 1
|
12.5 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
ART resumption: Creatine- Grade 1
|
12.5 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
ART resumption: Hyperglycemia- Grade 1
|
6.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
ART resumption: Hyperglycemia- Grade 2
|
6.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
ART resumption: Hypoglycemia- Grade 1
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
ART resumption: Hypoglycemia- Grade 2
|
6.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
ATP: Gamma Glutamyl Transferase (high)
|
5.9 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
ATP: Gamma Glutamyl Transferase (low)
|
0 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
ART resumption: Chloride (High)
|
18.8 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
ART resumption: Gamma Glutamyl Transferase (Low)
|
6.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
ART resumption: Urea Nitrogen (Low)
|
12.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities
ART Resumption: Bilirubin
|
0 percentage of participants
|
12.5 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 96Population: FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories.
Percentage of participants with worst laboratory toxicity grade 1 (mild) and non-graded hematology abnormalities were reported. Hematology parameters included absolute neutrophil count, basophils/leukocytes, eosinophils/leukocytes, hematocrit, lymphocytes/leukocytes, monocytes/leukocytes, neutrophils/leukocytes, erythrocytes, hematocrit, neutrophils, basophils, eosinophils, eosinophils/leukocytes, monocytes, neutrophils and platelet count. The parameters not represented in the grading scale, abnormalities were indicated as being 'high' or 'low' or 'abnormal'.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Eosinophils/Leukocytes (low)
|
17.6 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
Post-Any Dose: Neutrophils/Leukocytes (low)
|
5.9 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ATI: Eosinophils/Leukocytes (high)
|
0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ATI: Eosinophils/Leukocytes (low)
|
0 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ATI: Erythrocytes (low)
|
17.6 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
Post-Any Dose: Lymphocytes/Leukocytes (low)
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
Post-Any Dose: Monocytes/Leukocytes (high)
|
5.9 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ATI: Hematocrit (low)
|
23.5 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
Post-Any Dose: Lymphocytes/Leukocytes (high)
|
0 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Absolute Neutrophil Count-Grade 1
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
Post-Any Dose: Basophils/Leukocytes (high)
|
11.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
Post-Any Dose: Eosinophils/Leukocytes (high)
|
5.9 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
Post-Any Dose: Hematocrit (low)
|
5.9 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ATI: Lymphocytes/Leukocytes (high)
|
5.9 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ATI: Lymphocytes/Leukocytes (low)
|
0 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ATI: Monocytes/Leukocytes (high)
|
35.3 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ATI: Neutrophils (low)
|
11.8 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ATI: Neutrophils/Leukocytes (low)
|
5.9 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Basophils (high)
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Basophils/Leukocytes (high)
|
11.8 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Eosinophils (high)
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Eosinophils (low)
|
17.6 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Eosinophils/Leukocytes (high)
|
11.8 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Erythrocytes (high)
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Erythrocytes (low)
|
11.8 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Hematocrit (low)
|
29.4 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Lymphocytes/Leukocytes (high)
|
17.6 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Lymphocytes/Leukocytes (low)
|
11.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Monocytes/Leukocytes (high)
|
64.7 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Monocytes (high)
|
11.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Neutrophils (low)
|
41.2 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Neutrophils/Leukocytes (high)
|
0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
ART resumption: Neutrophils/Leukocytes (low)
|
29.4 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities
Platelet count
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: From Week 60 to Week 96Population: The primary Efficacy Population (EP) included all participants who started antiretroviral (ARV) ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.
Percentage of participants with sustained viremic control (HIV RNA \<50 copies/mL) during ATI phase were reported.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With Sustained Viremic Control (Human Immunodeficiency Virus [HIV] Ribonucleic Acid [RNA] Less Than [<]50 Copies Per Milliliter [Copies/mL]) During ATI Phase
|
0 percentage of participants
|
11.1 percentage of participants
|
PRIMARY outcome
Timeframe: From Week 60 to Week 96Population: The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.
Duration of sustained viremic control With HIV RNA \<50 copies/mL during ATI Phase was reported.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=1 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Duration of Sustained Viremic Control With HIV RNA <50 Copies/mL During ATI Phase
|
—
|
27.7 weeks
Here NA refers that upper and lower limit of Confidence interval cannot be calculated for 1 participant.
|
SECONDARY outcome
Timeframe: From Week 60 to Week 96Population: The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.
The total HIV DNA levels were assessed as a biomarker of the HIV reservoir.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Total HIV Deoxyribonucleic Acid (DNA) Levels Over Time
Start of ATI
|
34.83 copies/10E6 cells
Standard Deviation 54.04
|
80.10 copies/10E6 cells
Standard Deviation 117.36
|
|
Total HIV Deoxyribonucleic Acid (DNA) Levels Over Time
6 Months post ATI
|
47.24 copies/10E6 cells
Standard Deviation 67.49
|
80.00 copies/10E6 cells
Standard Deviation 72.52
|
SECONDARY outcome
Timeframe: Baseline and from Week 60 to Week 96Population: The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories.
Change in CD4 count over time was reported. Assessment of residual HIV replication and viral reservoir in total CD4+ T cells was measured by quantitative real-time polymerase chain reaction (PCR).
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Change in Cluster of Differentiation (CD)4 Count Over Time
Baseline
|
637 Median cells per cubic milliliters
Interval 545.0 to 757.0
|
531 Median cells per cubic milliliters
Interval 452.0 to 717.0
|
|
Change in Cluster of Differentiation (CD)4 Count Over Time
ATI
|
602 Median cells per cubic milliliters
Interval 542.0 to 730.0
|
498 Median cells per cubic milliliters
Interval 465.0 to 545.0
|
|
Change in Cluster of Differentiation (CD)4 Count Over Time
ART
|
661 Median cells per cubic milliliters
Interval 561.0 to 730.0
|
618 Median cells per cubic milliliters
Interval 485.0 to 775.5
|
|
Change in Cluster of Differentiation (CD)4 Count Over Time
Week 96
|
620 Median cells per cubic milliliters
Interval 556.0 to 753.0
|
538 Median cells per cubic milliliters
Interval 474.0 to 805.0
|
SECONDARY outcome
Timeframe: Up to Week 96Population: The primary EP included all participants who started ARV ATI at Week 60 (Stage 2), regardless of the time or outcome of treatment interruption.
Time to reinitiating ART was reported.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Time to Reinitiating ART
|
5.4 Weeks
Interval 4.64 to 6.18
|
4.5 Weeks
Interval 3.14 to 5.93
|
SECONDARY outcome
Timeframe: From Week 60 to Week 96Population: The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.
Number of participants with acute retroviral syndrome post-ARV ATI were reported.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Number of Participants With Acute Retroviral Syndrome Post-ARV ATI
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Week 60 to Week 96Population: The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.
Duration of acute retroviral syndrome post-ARV ATI was reported.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Duration of Acute Retroviral Syndrome Post-ARV ATI
|
NA weeks
No acute retroviral syndrome was reported during the study.
|
NA weeks
No acute retroviral syndrome was reported during the study.
|
SECONDARY outcome
Timeframe: From Week 60 to Week 96Population: The primary EP included all participants who started ARV ATI at Week 60 and interrupted at least one dose of ART (Stage 2), regardless of the time or outcome of treatment interruption.
Percentage of participants with HIV resistance to ARV drugs who experienced rebound viremia after ARV ATI were reported. An HIV genotype test was done to evaluate and characterize HIV resistance to ARV drugs in participants who experience rebound viremia after ARV ATI.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Participants With HIV Resistance to ARV Drugs Who Experienced Rebound Viremia After ARV ATI
|
35.3 percentage of participants
|
22.2 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 24, 26, 48 and 50Population: The Immunogenicity Population (IP) included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Frozen peripheral blood mononuclear cell (PBMCs) was analyzed by interferon-gamma (IFN-gamma) (ELISpot). The response was defined as post-baseline value \>P95 if baseline \<P95 or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=P95. The threshold for ELISpot test was based on the 95th percentile (P95) from the baseline values of participants on that test in the study.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV12 pep subpool (PTE): Week 26
|
11.8 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV12 pep subpool (PTE): Week 50
|
6.7 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV13 pep subpool (Mos1): Week 50
|
0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV13 pep subpool (Mos2): Week 26
|
21.4 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV13 pep subpool (PTE): Week 50
|
0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV14 pep subpool (Mos1): Week 50
|
20.0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV14 pep subpool (Mos2): Week 50
|
6.7 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV pep pool (Clinical PTE): Week 24
|
70.6 percentage of responders
|
11.1 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV pep pool (Clinical PTE): Week 26
|
100 percentage of responders
|
22.2 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV pep pool (Clinical PTE): Week 48
|
70.6 percentage of responders
|
22.2 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV pep pool (Clinical PTE): Week 50
|
80.0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV pep pool (Mos1): Week 26
|
94.1 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV pep pool (Mos1): Week 50
|
100 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV pep pool (Mos2): Week 26
|
58.8 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV pep pool (Mos2): Week 50
|
66.7 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV10 pep subpool (PTE): Week 26
|
11.8 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV10 pep subpool (PTE): Week 50
|
20.0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV11 pep subpool (Mos1): Week 26
|
0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV11 pep subpool (Mos1): Week 50
|
0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV11 pep subpool (Mos2): Week 26
|
0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV11 pep subpool (Mos2): Week 50
|
0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV11 pep subpool (PTE): Week 26
|
11.8 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV11 pep subpool (PTE): Week 50
|
0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV12 pep subpool (Mos1): Week 26
|
5.9 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV12 pep subpool (Mos1): Week 50
|
0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV12 pep subpool (Mos2): Week 26
|
0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV12 pep subpool (Mos2): Week 50
|
0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV13 pep subpool (Mos1): Week 26
|
0 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV13 pep subpool (Mos2): Week 50
|
6.7 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV13 pep subpool (PTE): Week 26
|
5.9 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV14 pep subpool (Mos1): Week 26
|
17.6 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50
HIV IFNg ENV14 pep subpool (Mos2): Week 26
|
14.3 percentage of responders
|
0 percentage of responders
|
SECONDARY outcome
Timeframe: At Week 24, 26, 48 and 50Population: The IP included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation.
The Env Clade A (92UG037), B (1990a), and C (Con C), (C97ZA.012) and Mos1- specific binding antibody titer were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline greater than or equal to (\>=) LLOQ. The lower limits of quantification (LLOQs) for this assay were 625, 156.25, 625, 156.25 and 78.125 endotoxin units per milliliter (EU/mL) for Clade A (92UG037), Clade B (1990a), Clade C (Con C), Clade C (C97ZA.012) and Mos1 respectively.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) A (92UG037.1) IgG-t Ab: Week 26
|
100 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) A (92UG037.1) IgG-t Ab: Week 48
|
94.1 percentage of responders
|
11.1 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) A (92UG037.1) IgG-t Ab: Week 50
|
100 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) B (1990a) IgG-t Ab: Week 24
|
100 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) B (1990a) IgG-t Ab: Week 26
|
100 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) B (1990a) IgG-t Ab: Week 48
|
100 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) B (1990a) IgG-t Ab: Week 50
|
100 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) C (ConC) IgG-t Ab: Week 24
|
94.1 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) C (ConC) IgG-t Ab: Week 26
|
70.6 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) C (ConC) IgG-t Ab: Week 48
|
82.4 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) C (ConC) IgG-t Ab: Week 50
|
94.1 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 4
|
76.5 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 16
|
82.4 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 24
|
82.4 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 26
|
82.4 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) C (ZA) IgG-t Ab; Week 48
|
64.7 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) C (ZA) IgG-t Ab: Week 50
|
76.5 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) Mos1 IgG-t Ab: Week 24
|
88.2 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) Mos1 IgG-t Ab; Week 26
|
100 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) Mos1 IgG-t Ab: Week 48
|
94.1 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) Mos1 IgG-t Ab: Week 50
|
94.1 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers
HIV ENV (gp140 T) A (92UG037.1) IgG-t Ab: Week 24
|
100 percentage of responders
|
11.1 percentage of responders
|
SECONDARY outcome
Timeframe: Week 50Population: The IP included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.
Vaccine-induced binding antibody IgG1, IgG2, and IgG3 subclass responses were investigated using Clade C (C97ZA.012) specific ELISAs. The response was defined as post-baseline value \>LLOQ if baseline \<LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=LLOQ. The LLOQs for this assay were 12.3, 28.7, and 12.4, for IgG1, IgG2, and IgG3, respectively. Less participants were assessed for IgG2 responses due to lack of sample volume which led to a limit on the number of repeats that the analysis lab could perform. Reportable results were not generated for the remaining participants post vaccination.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Responders for Clade C (C97ZA.012) Env ELISA Immunoglobulin G1 (IgG1), IgG2, and IgG3 Glycoprotein (gp) 140 Binding Antibody
HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab
|
68.8 percentage of responders
|
0 percentage of responders
|
|
Percentage of Responders for Clade C (C97ZA.012) Env ELISA Immunoglobulin G1 (IgG1), IgG2, and IgG3 Glycoprotein (gp) 140 Binding Antibody
HIV ENV (gp140 T) clade C (ZA) IgG-2 Ab
|
0 percentage of responders
|
—
|
|
Percentage of Responders for Clade C (C97ZA.012) Env ELISA Immunoglobulin G1 (IgG1), IgG2, and IgG3 Glycoprotein (gp) 140 Binding Antibody
HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab
|
18.8 percentage of responders
|
11.1 percentage of responders
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 26 and 50Population: The IP included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation.
Breadth of T cell responses was assessed at baseline (Week 0), Week 26, and Week 50 by ELISPOT assays.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Breadth of T Cell Responses Analyzed by ELISPOT Assays
Baseline
|
2.0 Median number of subpools
Interval 0.0 to 7.0
|
3.5 Median number of subpools
Interval 0.0 to 11.0
|
|
Breadth of T Cell Responses Analyzed by ELISPOT Assays
Week 26
|
10.0 Median number of subpools
Interval 3.0 to 23.0
|
3.0 Median number of subpools
Interval 0.0 to 8.0
|
|
Breadth of T Cell Responses Analyzed by ELISPOT Assays
Week 50
|
8.0 Median number of subpools
Interval 4.0 to 12.0
|
3.0 Median number of subpools
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: At Week 24, 26, 48 and 50Population: The IP included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation.
The functionality of vaccine-induced antibody responses was investigated by the determination of ADCP. The response was defined as post-baseline value \> limit of detection (LOD) if baseline \<LOD or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=LOD. The lower limits of detection (LODs) for this assay were 4.28 (phagocytic score) for Mos1.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time
Week 24
|
4.500 percentage of ADCP gp antibody
Interval 0.0 to 37.6
|
0 percentage of ADCP gp antibody
Interval 0.0 to 1.0
|
|
Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time
Week 26
|
18.200 percentage of ADCP gp antibody
Interval 0.0 to 50.0
|
0 percentage of ADCP gp antibody
Interval 0.0 to 0.8
|
|
Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time
Week 48
|
10.500 percentage of ADCP gp antibody
Interval 0.0 to 44.2
|
0 percentage of ADCP gp antibody
Interval 0.0 to 1.8
|
|
Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time
Week 50
|
20.500 percentage of ADCP gp antibody
Interval 0.0 to 49.0
|
0 percentage of ADCP gp antibody
Interval 0.0 to 12.9
|
SECONDARY outcome
Timeframe: Week 64Population: The IP included all participants who were randomized and received at least 3 vaccinations according to the protocol-specified vaccination schedule, excluding the participant with a major protocol deviation.
The functionality of vaccine-induced antibody responses was investigated by the determination of nAb activity in a virus neutralization assay (VNA) using TZM-bl cells and Env-pseudotyped viruses. The response was defined as post-baseline value \>LLOQ.
Outcome measures
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 Participants
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 Participants
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Percentage of Responders for HIV Neutralizing Antibody (nAb)
|
100 percentage of responders
|
0 percentage of responders
|
Adverse Events
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 participants at risk
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 participants at risk
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Cardiac disorders
Tachycardia
|
5.9%
1/17 • Number of events 1 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
Other adverse events
| Measure |
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
n=17 participants at risk
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
Placebo
n=9 participants at risk
Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Gastrointestinal disorders
Anogenital Dysplasia
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
General disorders
Feeling Hot
|
17.6%
3/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
22.2%
2/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Immune system disorders
Food Allergy
|
0.00%
0/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Infections and infestations
Anal Chlamydia Infection
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Infections and infestations
Chlamydial Infection
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Infections and infestations
Oropharyngeal Gonococcal Infection
|
0.00%
0/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Infections and infestations
Syphilis
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
23.5%
4/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Infections and infestations
Urethritis
|
0.00%
0/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Infections and infestations
Urethritis Chlamydial
|
0.00%
0/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Investigations
Cd4 Lymphocytes Decreased
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Investigations
Hepatic Enzyme Increased
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Investigations
Liver Function Test Increased
|
17.6%
3/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Investigations
Weight Decreased
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Metabolism and nutrition disorders
Abnormal Loss of Weight
|
0.00%
0/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Metabolism and nutrition disorders
Folate Deficiency
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Metabolism and nutrition disorders
Hypophagia
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
11.1%
1/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
11.8%
2/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
0.00%
0/9 • Up to Week 96
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
|
Additional Information
CLINICAL FRANCHISE LEADER
Janssen Vaccines and Prevention BV
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER