Trial Outcomes & Findings for Vaccine Therapy in Preventing HPV in HIV-Positive Women in India (NCT NCT00667563)

NCT ID: NCT00667563

Last Updated: 2024-03-19

Results Overview

Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 150 participants
• Primary outcome timeframe: 52 weeks from study entry
• Results posted on: 2024-03-19

Participant Flow

Participant milestones

Measure	Gardasil Vaccination Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52.
Overall Study STARTED	150
Overall Study COMPLETED	126
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Measure

Gardasil Vaccination Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52.

Overall Study Protocol Violation

24

Baseline Characteristics

Vaccine Therapy in Preventing HPV in HIV-Positive Women in India

Baseline characteristics by cohort

Measure	Gardasil Vaccination n=150 Participants Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52.
Age, Continuous	30.8 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks from study entry

Population: Intent-to-treat

Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients

Outcome measures

Measure

Gardasil Vaccination n=150 Participants Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52.

Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0

6.0 Grade 3/4 adverse events per 100 patient Interval 3.12 to 11.58

PRIMARY outcome

Timeframe: Screening/Week 0, Weeks 2, 10, 26, and 52.

Population: Intent-to-treat

Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests

Outcome measures

Measure

Gardasil Vaccination n=150 Participants Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52.

Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count

11 participants Interval 3.77 to 12.91

PRIMARY outcome

Timeframe: Week 28

Population: Per-protocol population with undetectable HPV-16 levels at baseline

Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline

Outcome measures

Measure

Gardasil Vaccination n=96 Participants Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52.

Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28

95 participants

PRIMARY outcome

Timeframe: Screening/week 0, weeks, 2, 10, 26 and 52

Number of patients with a significant increase in HIV viral load defined as > 1 log increase in HIV load from baseline on 2 consecutive occasions

Outcome measures

Measure

Gardasil Vaccination n=150 Participants Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52.

Number of Patients With a Significant Increase in HIV Viral Load

7 participants Interval 1.95 to 9.63

PRIMARY outcome

Timeframe: 28 weeks

Population: Per-protocol participants with undetectable antibodies to HPV-6 at baseline

Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline

Outcome measures

Measure

Gardasil Vaccination n=88 Participants Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52.

Number of Patients With Detectable Antibodies to HPV-6

88 participants

PRIMARY outcome

Timeframe: 28 weeks

Population: Per-protocol population of participants with undetectable antibodies for HPV-11 at baseline

Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline

Outcome measures

Measure

Gardasil Vaccination n=111 Participants Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52.

Number of Patients With Detectable Antibodies to HPV-11

110 participants

PRIMARY outcome

Timeframe: 28 weeks

Population: Per-protocol population of participants with undetectable HPV-18 antibodies at baseline

Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline

Outcome measures

Measure

Gardasil Vaccination n=104 Participants Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52.

Number of Patients With Detectable Antibodies to HPV-18

94 participants

Adverse Events

Gardasil Vaccination

Serious events: 4 serious events

Other events: 145 other events

Deaths: 0 deaths

Serious adverse events

Measure	Gardasil Vaccination n=150 participants at risk Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52.
Blood and lymphatic system disorders Anemia	0.67% 1/150 • Number of events 1
General disorders Fever	0.67% 1/150 • Number of events 1
Infections and infestations Meningitis	0.67% 1/150 • Number of events 1
Infections and infestations Lung Infection	0.67% 1/150 • Number of events 1
Infections and infestations Leptospirosis	0.67% 1/150 • Number of events 1
Nervous system disorders Seizure	0.67% 1/150 • Number of events 1

Other adverse events

Measure	Gardasil Vaccination n=150 participants at risk Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. DNA analysis: Weeks 0, 2, 10, 26, and 52. polymerase chain reaction: Screening, week 36, and week 52. cytology specimen collection procedure: Screening, week 36, and week 52. colposcopic biopsy: Screening, week 36, and week 52.
Gastrointestinal disorders Abdominal pain	23.3% 35/150 • Number of events 41
Gastrointestinal disorders Dyspepsia	12.7% 19/150 • Number of events 22
Gastrointestinal disorders Vomiting	6.7% 10/150 • Number of events 11
General disorders Fatigue	18.0% 27/150 • Number of events 32
Infections and infestations Lung Infection	5.3% 8/150 • Number of events 8
Infections and infestations Skin Infection	17.3% 26/150 • Number of events 29
Infections and infestations Upper Respiratory Infection	29.3% 44/150 • Number of events 60
Infections and infestations Vaginal Infection	14.0% 21/150 • Number of events 22
Infections and infestations Vulval Infection	6.7% 10/150 • Number of events 10
Metabolism and nutrition disorders Anorexia	14.0% 21/150 • Number of events 24
Musculoskeletal and connective tissue disorders Arthralgia	6.0% 9/150 • Number of events 11
Musculoskeletal and connective tissue disorders Back pain	18.0% 27/150 • Number of events 40
Musculoskeletal and connective tissue disorders Myalgia	16.7% 25/150 • Number of events 34
Musculoskeletal and connective tissue disorders Pain in extremity	30.0% 45/150 • Number of events 61
Nervous system disorders Headache	22.7% 34/150 • Number of events 47
Reproductive system and breast disorders Vaginal Discharge	14.0% 21/150 • Number of events 27
Reproductive system and breast disorders Cough	39.3% 59/150 • Number of events 87
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	12.0% 18/150 • Number of events 22
Skin and subcutaneous tissue disorders Pruritus	27.3% 41/150 • Number of events 64
Skin and subcutaneous tissue disorders Rash, maculo-papular	9.3% 14/150 • Number of events 16

Additional Information

Jeannette Y. Lee

AMC

Phone: 5015266712

Email: jylee@uams.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place