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

Merck Sharp & Dohme LLC2,409 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

2,409

Conditions

HPV 16 Infection

Interventions

Comparator: HPV 16 L1 VaccineBIOLOGICAL

A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6

Comparator: PlaceboBIOLOGICAL

A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 23 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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".

Time frame: Month 7

Data from ClinicalTrials.gov

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