Trial Outcomes & Findings for Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children (NCT NCT00339040)

Last Updated: 2021-11-05

Results Overview

Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities attributed to study treatment were included. The relationship between the Adverse Events and the vaccination were evaluated by study team and assigned to, for example, "Treatment related", "Non-treatment related", "Baseline", "Possibly treatment related".

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

130 participants

Primary outcome timeframe

Within 14 days of first three doses of vaccination

Results posted on

2021-11-05

Participant Flow

Between October 11, 2006 and November 22, 2006 130 participants were enrolled at 34 clinical sites from US \& Puerto Rico.

Participants were stratified by CD4% criteria. Four participants were randomized but did not receive the study treatment. The study analyses were based on 126 participants who received the study treatment.

Participant milestones

Participant milestones
Measure	Arm A QHPV Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.	Arm B Placebo/QHPV Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Stage I STARTED	96	30
Stage I Vaccination 1 at Week 0	96	30
Stage I Vaccination 2 at Week 8	95	30
Stage I Vaccination 3 at Week 24	94	30
Stage I COMPLETED	94	29
Stage I NOT COMPLETED	2	1
Stage II STARTED	94	29
Stage II Vaccination 4 at Week 96	84	29
Stage II Vaccination 5 at Week 104	0	28
Stage II Vaccination 6 at Week 120	0	27
Stage II COMPLETED	84	27
Stage II NOT COMPLETED	10	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A QHPV Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.	Arm B Placebo/QHPV Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Stage I Not able to attend clinic	1	0
Stage I Protocol Violation	1	1
Stage II Lost to Follow-up	3	0
Stage II Withdrawal by Subject	1	2
Stage II Protocol Violation	3	0
Stage II Not able to attend clinic	1	0
Stage II Site closing	2	0

Baseline Characteristics

Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A QHPV n=96 Participants Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.	Arm B Placebo/QHPV n=30 Participants Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.	Total n=126 Participants Total of all reporting groups
Age, Continuous	10.0 years STANDARD_DEVIATION 1.4 • n=5 Participants	9.9 years STANDARD_DEVIATION 1.3 • n=7 Participants	9.9 years STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	18 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	12 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Black, non-Hispanic	54 participants n=5 Participants	11 participants n=7 Participants	65 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	37 participants n=5 Participants	14 participants n=7 Participants	51 participants n=5 Participants
Race/Ethnicity, Customized Others	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Stratification groups Stratum A	31 participants n=5 Participants	10 participants n=7 Participants	41 participants n=5 Participants
Stratification groups Stratum B	32 participants n=5 Participants	11 participants n=7 Participants	43 participants n=5 Participants
Stratification groups Stratum C	33 participants n=5 Participants	9 participants n=7 Participants	42 participants n=5 Participants
CD4 count	868 cells/µL STANDARD_DEVIATION 367 • n=5 Participants	1013 cells/µL STANDARD_DEVIATION 455 • n=7 Participants	903 cells/µL STANDARD_DEVIATION 393 • n=5 Participants
CD4%	33.9 percentage of total lymphocytes STANDARD_DEVIATION 7.9 • n=5 Participants	35.8 percentage of total lymphocytes STANDARD_DEVIATION 8.6 • n=7 Participants	34.3 percentage of total lymphocytes STANDARD_DEVIATION 8.1 • n=5 Participants
Log10(RNA)	2.7 Log10(copies/mL) STANDARD_DEVIATION 0.9 • n=5 Participants	2.6 Log10(copies/mL) STANDARD_DEVIATION 0.8 • n=7 Participants	2.7 Log10(copies/mL) STANDARD_DEVIATION 0.9 • n=5 Participants
RNA group ≤400 copies/mL	65 participants n=5 Participants	22 participants n=7 Participants	87 participants n=5 Participants
RNA group 401 to ≤5000 copies/mL	16 participants n=5 Participants	5 participants n=7 Participants	21 participants n=5 Participants
RNA group >5000 copies/mL	15 participants n=5 Participants	3 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 14 days of first three doses of vaccination

Population: Any participant who received at least one study vaccine/placebo were included in the safety analysis.

Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). The grades used are: Grade 1="Mild", Grade 2="Moderate", Grade 3="Severe", Grade 4="Potentially Life-Threatening". All grade 3 and higher signs, symptoms, and laboratory toxicities were included.

Outcome measures

Outcome measures
Measure	Arm A QHPV n=96 Participants Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.	Arm B Placebo/QHPV n=30 Participants Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs)	7.3 percent of participants Interval 3.0 to 14.5	6.7 percent of participants Interval 0.8 to 22.1

PRIMARY outcome

Timeframe: Within 14 days of first three doses of vaccination

Population: Any participant who received at least one study vaccine/placebo were included in the safety analysis

Outcome measures

Outcome measures
Measure	Arm A QHPV n=96 Participants Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.	Arm B Placebo/QHPV n=30 Participants Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment	0 percent of participants Interval 0.0 to 0.0	0 percent of participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: At week 28 after beginning the vaccination series

Population: The type-specific results are reported for participants remaining after exclusion of those with protocol violations, unevaluable specimens, or the presence of type-specific sero-positive antibody at baseline.

Serum anti-HPV 6, 11, 16, and 18 antibody was measured using a competitive Luminex immunoassay (cLIA; reported in milli-Merck Units \[mMU\]/mL). Sero-positivity was defined as an anti-HPV titer ≥20, 16, 20, and 24 mMU/mL, for HPV types 6, 11, 16, and 18, respectively.

Outcome measures

Outcome measures
Measure	Arm A QHPV n=96 Participants Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.	Arm B Placebo/QHPV n=30 Participants Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion Serotype 6	100.0 percent of participants Interval 95.9 to 100.0	0.0 percent of participants Interval 0.0 to 12.8
Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion Serotype 11	100.0 percent of participants Interval 95.9 to 100.0	0.0 percent of participants Interval 0.0 to 12.8
Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion Serotype 16	100.0 percent of participants Interval 95.9 to 100.0	3.7 percent of participants Interval 0.1 to 19.0
Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion Serotype 18	96.7 percent of participants Interval 90.6 to 99.3	0.0 percent of participants Interval 0.0 to 12.8

PRIMARY outcome

Timeframe: Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124.

Geometric means of Type-specific Serum anti-HPV antibody titers (cLIA)

Outcome measures

Outcome measures
Measure	Arm A QHPV n=96 Participants Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.	Arm B Placebo/QHPV n=30 Participants Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Serum Anti-HPV Antibody Titers (cLIA) Serotype 18 study entry	5.1 milli-Merck units [mMU]/mL Interval 4.9 to 5.3	5.0 milli-Merck units [mMU]/mL Interval 5.0 to 5.0
Serum Anti-HPV Antibody Titers (cLIA) Serotype 6 study entry	3.8 milli-Merck units [mMU]/mL Interval 3.5 to 4.1	4.1 milli-Merck units [mMU]/mL Interval 3.4 to 4.9
Serum Anti-HPV Antibody Titers (cLIA) Serotype 6 week 28	544.2 milli-Merck units [mMU]/mL Interval 395.4 to 749.1	4.5 milli-Merck units [mMU]/mL Interval 3.7 to 5.4
Serum Anti-HPV Antibody Titers (cLIA) Serotype 6 week 72	256.4 milli-Merck units [mMU]/mL Interval 196.5 to 334.7	4.3 milli-Merck units [mMU]/mL Interval 3.6 to 5.1
Serum Anti-HPV Antibody Titers (cLIA) Serotype 6 week 96	227.9 milli-Merck units [mMU]/mL Interval 167.3 to 310.3	4.5 milli-Merck units [mMU]/mL Interval 3.6 to 5.8
Serum Anti-HPV Antibody Titers (cLIA) Serotype 6 week 97	1604.8 milli-Merck units [mMU]/mL Interval 1162.0 to 2216.1	17.1 milli-Merck units [mMU]/mL Interval 7.1 to 41.5
Serum Anti-HPV Antibody Titers (cLIA) Serotype 6 week 100	2473.6 milli-Merck units [mMU]/mL Interval 1770.2 to 3456.4	79.7 milli-Merck units [mMU]/mL Interval 43.7 to 145.3
Serum Anti-HPV Antibody Titers (cLIA) Serotype 6 week 124	—	678.8 milli-Merck units [mMU]/mL Interval 396.4 to 1162.2
Serum Anti-HPV Antibody Titers (cLIA) Serotype 11 study entry	4.1 milli-Merck units [mMU]/mL Interval 3.9 to 4.2	4.0 milli-Merck units [mMU]/mL Interval 4.0 to 4.0
Serum Anti-HPV Antibody Titers (cLIA) Serotype 11 week 28	1396.6 milli-Merck units [mMU]/mL Interval 1103.8 to 1767.1	4.2 milli-Merck units [mMU]/mL Interval 3.8 to 4.7
Serum Anti-HPV Antibody Titers (cLIA) Serotype 11 week 72	313.1 milli-Merck units [mMU]/mL Interval 234.4 to 418.3	4.1 milli-Merck units [mMU]/mL Interval 3.9 to 4.5
Serum Anti-HPV Antibody Titers (cLIA) Serotype 11 week 96	286.5 milli-Merck units [mMU]/mL Interval 207.1 to 396.4	4.0 milli-Merck units [mMU]/mL Interval 4.0 to 4.0
Serum Anti-HPV Antibody Titers (cLIA) Serotype 11 week 97	1931.7 milli-Merck units [mMU]/mL Interval 1389.1 to 2686.3	11.8 milli-Merck units [mMU]/mL Interval 5.5 to 25.6
Serum Anti-HPV Antibody Titers (cLIA) Serotype 11 week 100	3611.2 milli-Merck units [mMU]/mL Interval 2746.8 to 4747.6	86.4 milli-Merck units [mMU]/mL Interval 48.7 to 153.6
Serum Anti-HPV Antibody Titers (cLIA) Serotype 11 week 124	—	1023.0 milli-Merck units [mMU]/mL Interval 704.2 to 1486.0
Serum Anti-HPV Antibody Titers (cLIA) Serotype 16 study entry	5.5 milli-Merck units [mMU]/mL Interval 5.5 to 5.5	5.5 milli-Merck units [mMU]/mL Interval 5.5 to 5.5
Serum Anti-HPV Antibody Titers (cLIA) Serotype 16 week 28	5172.5 milli-Merck units [mMU]/mL Interval 3889.8 to 6878.2	5.7 milli-Merck units [mMU]/mL Interval 5.3 to 6.2
Serum Anti-HPV Antibody Titers (cLIA) Serotype 16 week 72	1126.4 milli-Merck units [mMU]/mL Interval 788.6 to 1609.0	5.5 milli-Merck units [mMU]/mL Interval 5.5 to 5.5
Serum Anti-HPV Antibody Titers (cLIA) Serotype 16 week 96	1034.5 milli-Merck units [mMU]/mL Interval 708.8 to 1509.7	5.5 milli-Merck units [mMU]/mL Interval 5.5 to 5.5
Serum Anti-HPV Antibody Titers (cLIA) Serotype 16 week 97	6167.8 milli-Merck units [mMU]/mL Interval 4391.8 to 8661.8	12.1 milli-Merck units [mMU]/mL Interval 5.4 to 27.1
Serum Anti-HPV Antibody Titers (cLIA) Serotype 16 week 100	11205.6 milli-Merck units [mMU]/mL Interval 8184.7 to 15341.5	142.6 milli-Merck units [mMU]/mL Interval 74.1 to 274.5
Serum Anti-HPV Antibody Titers (cLIA) Serotype 16 week 124	—	4113.8 milli-Merck units [mMU]/mL Interval 2404.2 to 7039.3
Serum Anti-HPV Antibody Titers (cLIA) Serotype 18 week 28	931.2 milli-Merck units [mMU]/mL Interval 616.7 to 1406.0	5.0 milli-Merck units [mMU]/mL Interval 5.0 to 5.0
Serum Anti-HPV Antibody Titers (cLIA) Serotype 18 week 72	148.2 milli-Merck units [mMU]/mL Interval 92.5 to 237.4	5.0 milli-Merck units [mMU]/mL Interval 5.0 to 5.0
Serum Anti-HPV Antibody Titers (cLIA) Serotype 18 week 96	142.0 milli-Merck units [mMU]/mL Interval 86.6 to 232.8	5.0 milli-Merck units [mMU]/mL Interval 5.0 to 5.0
Serum Anti-HPV Antibody Titers (cLIA) Serotype 18 week 97	925.7 milli-Merck units [mMU]/mL Interval 567.6 to 1510.0	7.1 milli-Merck units [mMU]/mL Interval 4.6 to 11.0
Serum Anti-HPV Antibody Titers (cLIA) Serotype 18 week 100	1530.7 milli-Merck units [mMU]/mL Interval 991.7 to 2362.4	18.7 milli-Merck units [mMU]/mL Interval 10.6 to 32.8
Serum Anti-HPV Antibody Titers (cLIA) Serotype 18 week 124	—	734.3 milli-Merck units [mMU]/mL Interval 357.3 to 1508.8

SECONDARY outcome

Timeframe: Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.

Population: Any participant who received at least one study vaccine/placebo and with non-missing CD4 counts at the respective time point.

Outcome measures

Outcome measures
Measure	Arm A QHPV n=96 Participants Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.	Arm B Placebo/QHPV n=30 Participants Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
CD4 Count Over Time CD4 count at study entry	868 cells/µL Interval 794.0 to 942.0	1013 cells/µL Interval 843.0 to 1183.0
CD4 Count Over Time CD4 count at week 8	907 cells/µL Interval 830.0 to 985.0	1018 cells/µL Interval 851.0 to 1185.0
CD4 Count Over Time CD4 count at week 12	906 cells/µL Interval 828.0 to 983.0	1056 cells/µL Interval 830.0 to 1282.0
CD4 Count Over Time CD4 count at week 24	864 cells/µL Interval 792.0 to 936.0	993 cells/µL Interval 826.0 to 1160.0
CD4 Count Over Time CD4 count at week 28	875 cells/µL Interval 800.0 to 950.0	959 cells/µL Interval 803.0 to 1115.0
CD4 Count Over Time CD4 count at week 72	823 cells/µL Interval 746.0 to 900.0	933 cells/µL Interval 768.0 to 1098.0
CD4 Count Over Time CD4 count at week 96	781 cells/µL Interval 712.0 to 849.0	874 cells/µL Interval 718.0 to 1031.0
CD4 Count Over Time CD4 count at week 100	831 cells/µL Interval 754.0 to 907.0	924 cells/µL Interval 766.0 to 1083.0
CD4 Count Over Time CD4 count at week 104	—	929 cells/µL Interval 776.0 to 1082.0
CD4 Count Over Time CD4 count at week 108	839 cells/µL Interval 757.0 to 921.0	980 cells/µL Interval 786.0 to 1174.0
CD4 Count Over Time CD4 count at week 120	—	931 cells/µL Interval 745.0 to 1117.0
CD4 Count Over Time CD4 count at week 124	—	920 cells/µL Interval 728.0 to 1112.0

SECONDARY outcome

Timeframe: Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.

Population: Any participant who received at least one study vaccine/placebo and with non-missing CD4%.

Outcome measures

Outcome measures
Measure	Arm A QHPV n=96 Participants Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.	Arm B Placebo/QHPV n=30 Participants Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
CD4 Percent Over Time CD4 percent at study entry	34 percentage of total lymphocytes Interval 32.0 to 35.0	36 percentage of total lymphocytes Interval 33.0 to 39.0
CD4 Percent Over Time CD4 percent at week 8	34 percentage of total lymphocytes Interval 32.0 to 35.0	36 percentage of total lymphocytes Interval 33.0 to 39.0
CD4 Percent Over Time CD4 percent at week 12	35 percentage of total lymphocytes Interval 33.0 to 37.0	37 percentage of total lymphocytes Interval 33.0 to 41.0
CD4 Percent Over Time CD4 percent at week 24	34 percentage of total lymphocytes Interval 33.0 to 36.0	35 percentage of total lymphocytes Interval 31.0 to 39.0
CD4 Percent Over Time CD4 percent at week 28	34 percentage of total lymphocytes Interval 33.0 to 36.0	34 percentage of total lymphocytes Interval 31.0 to 38.0
CD4 Percent Over Time CD4 percent at week 72	33 percentage of total lymphocytes Interval 32.0 to 35.0	34 percentage of total lymphocytes Interval 30.0 to 38.0
CD4 Percent Over Time CD4 percent at week 96	33 percentage of total lymphocytes Interval 32.0 to 35.0	34 percentage of total lymphocytes Interval 30.0 to 38.0
CD4 Percent Over Time CD4 percent at week 100	35 percentage of total lymphocytes Interval 33.0 to 37.0	35 percentage of total lymphocytes Interval 32.0 to 39.0
CD4 Percent Over Time CD4 percent at week 104	—	36 percentage of total lymphocytes Interval 32.0 to 40.0
CD4 Percent Over Time CD4 percent at week 108	35 percentage of total lymphocytes Interval 33.0 to 37.0	34 percentage of total lymphocytes Interval 30.0 to 38.0
CD4 Percent Over Time CD4 percent at week 120	—	37 percentage of total lymphocytes Interval 32.0 to 42.0
CD4 Percent Over Time CD4 percent at week 124	—	35 percentage of total lymphocytes Interval 31.0 to 39.0

SECONDARY outcome

Timeframe: Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.

Population: Any participant who received at least one study vaccine/placebo and with non-missing HIV-1 viral load at the respective time point.

Outcome measures

Outcome measures
Measure	Arm A QHPV n=96 Participants Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.	Arm B Placebo/QHPV n=30 Participants Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time Log10(RNA) at study entry	2.7 Log10 (copies/mL) Interval 2.5 to 2.9	2.6 Log10 (copies/mL) Interval 2.3 to 2.9
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time Log10(RNA) at week 8	2.8 Log10 (copies/mL) Interval 2.6 to 3.0	2.8 Log10 (copies/mL) Interval 2.5 to 3.1
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time Log10(RNA) at week 12	2.7 Log10 (copies/mL) Interval 2.6 to 2.9	2.8 Log10 (copies/mL) Interval 2.5 to 3.2
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time Log10(RNA) at week 24	2.8 Log10 (copies/mL) Interval 2.6 to 2.9	2.7 Log10 (copies/mL) Interval 2.4 to 3.1
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time Log10(RNA) at week 28	2.7 Log10 (copies/mL) Interval 2.6 to 2.9	2.8 Log10 (copies/mL) Interval 2.4 to 3.1
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time Log10(RNA) at week 72	2.7 Log10 (copies/mL) Interval 2.5 to 2.8	2.7 Log10 (copies/mL) Interval 2.4 to 3.1
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time Log10(RNA) at week 96	2.6 Log10 (copies/mL) Interval 2.4 to 2.8	2.4 Log10 (copies/mL) Interval 2.1 to 2.6
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time Log10(RNA) at week 100	2.6 Log10 (copies/mL) Interval 2.4 to 2.8	2.4 Log10 (copies/mL) Interval 2.1 to 2.6
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time Log10(RNA) at week 104	—	2.4 Log10 (copies/mL) Interval 2.0 to 2.7
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time Log10(RNA) at week 108	2.6 Log10 (copies/mL) Interval 2.4 to 2.7	2.5 Log10 (copies/mL) Interval 2.1 to 2.8
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time Log10(RNA) at week 120	—	2.3 Log10 (copies/mL) Interval 2.0 to 2.6
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time Log10(RNA) at week 124	—	2.3 Log10 (copies/mL) Interval 1.9 to 2.6

Adverse Events

Arm A QHPV

Serious events: 5 serious events

Other events: 93 other events

Deaths: 0 deaths

Arm B Placebo/QHPV

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A QHPV n=96 participants at risk Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.	Arm B Placebo/QHPV n=30 participants at risk Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Blood and lymphatic system disorders Neutropenia	2.1% 2/96 • Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date). Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.00% 0/30 • Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date). Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
General disorders Oedema peripheral	0.00% 0/96 • Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date). Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	3.3% 1/30 • Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date). Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Blood amylase increased	1.0% 1/96 • Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date). Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.00% 0/30 • Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date). Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Blood bilirubin increased	1.0% 1/96 • Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date). Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.00% 0/30 • Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date). Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Blood bilirubin unconjugated increased	0.00% 0/96 • Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date). Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	3.3% 1/30 • Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date). Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Investigations Neutrophil count decreased	1.0% 1/96 • Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date). Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.	0.00% 0/30 • Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date). Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.

Other adverse events

Additional Information

Melissa Allen, Director, IMPAACT Operations Center

Family Health International (FHI 360)

Phone: (919) 405-1429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and Merck \& Co., Inc., NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER