Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)

Study Overview
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Brief Summary
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Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.

Official Title
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Study of Pilot Manufacturing Lot of HPV 16 Virus-Like Particle (VLP) Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females

Conditions
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HPV 16 Infection

Intervention / Treatment
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* Biological: Comparator: HPV 16 L1 Vaccine
* Biological: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, unmarried females age 16 to 23 years with intact uteri Not pregnant at enrollment Agreed to use effective contraception through Month 7 of the study A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive intercourse Exclusion Criteria: No prior history of Human Papillomavirus (HPV) vaccination No receipt of any other vaccination within 1 month prior to enrollment or plans to receive any other vaccination within 1 month prior to or after any dose of study vaccine No prior history of an abnormal Papanicolaou (Pap) test showing Squamous intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia (CIN)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 23 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>HPV 16 L1 VLP vaccine | Biological: Comparator: HPV 16 L1 Vaccine<br>* A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6<br>* Other names: V501;|
| Placebo Comparator: 2<br>Placebo | Biological: Comparator: Placebo<br>* A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Persistent HPV 16 Infection | Cases of persistent infection were those with detection of HPV 16 by PCR (Polymerase chain reaction) on at least 2 consecutive visits at least 4 months apart; or detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1 (Cervical intraepithelial neoplasia), CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy; or detection of HPV 16 on a subject's last visit. | Through Month 48 | 
| Incidence of HPV 16-related CIN1, CIN2 or C1N3 | Cases of HPV 16-related CIN1, CIN2 or CIN3 are those with detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1, CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy. | Through Month 48 | 
| Serum Anti-HPV 16 Geometric Mean Titers | The limit of detection of the assay was 6 mMU/ml. Samples with titer below the limit of detection were assigned a value of 3 for calculation of GMT and confidence interval. GMTs and confidence limits below the limit of detection are shown as 6.0. | Month 7 |