NCT00851643 · REGISTRY CONDITION SEARCH

Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2016-02-03

This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A

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outcome · POSTED

Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B

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outcome · POSTED

Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A

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outcome · POSTED

Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Participant is in good physical health * Participant has had a lifetime history of 0 to 4 sexual partners * Females between 18-to-24 years Exclusion Criteria: * Participant has a history of abnormal Pap test * Participant has a history of positive test for HPV * Participant has a history of recent or ongoing alcohol or drug abuse * Participant is immunocompromised or has an autoimmune condition * Participant has received immunosuppressive therapy within a year of screening * Participant has previously received an HPV vaccine * Participant is pregnant * Participant has a history of external genital/vaginal warts * Participant is currently enrolled in a clinical trial * Participant has a history of a severe allergic reaction that required medical attention
healthy Volunteers: true
maximum Age: 24 Years
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT

Treatment arms and interventions

arm Groups

description
Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS) and Octavalent HPV with 30 mcg IMX / AAHS during Phase A.
intervention Names
Biological: Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
label
qHPV (GARDASIL™) - Phase A Control
type
ACTIVE_COMPARATOR
description
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg AAHS and 15 mcg IMX.
intervention Names
Biological: Octavalent HPV with 15 mcg IMX / AAHS
label
Octavalent HPV with 15 mcg IMX / AAHS
type
EXPERIMENTAL
description
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX.
intervention Names
Biological: Octavalent HPV with 30 mcg IMX / AAHS
label
Octavalent HPV with 30 mcg IMX / AAHS
type
EXPERIMENTAL
description
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 60 mcg IMX / AAHS and Octavalent HPV with 120 mcg IMX / AAHS during Phase B.
intervention Names
Biological: Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
label
qHPV (GARDASIL™) - Phase B Control
type
ACTIVE_COMPARATOR
description
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX.
intervention Names
Biological: Octavalent HPV with 60 mcg IMX / AAHS
label
Octavalent HPV with 60 mcg IMX / AAHS
type
EXPERIMENTAL
description
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX.
intervention Names
Biological: Octavalent HPV with 120 mcg IMX / AAHS
label
Octavalent HPV with 120 mcg IMX / AAHS
type
EXPERIMENTAL

interventions

arm Group Labels
Octavalent HPV with 15 mcg IMX / AAHS
description
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
name
Octavalent HPV with 15 mcg IMX / AAHS
other Names
V502
type
BIOLOGICAL
arm Group Labels
Octavalent HPV with 30 mcg IMX / AAHS
description
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
name
Octavalent HPV with 30 mcg IMX / AAHS
other Names
V502
type
BIOLOGICAL
arm Group Labels
Octavalent HPV with 60 mcg IMX / AAHS
description
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
name
Octavalent HPV with 60 mcg IMX / AAHS
other Names
V502
type
BIOLOGICAL
arm Group Labels
Octavalent HPV with 120 mcg IMX / AAHS
description
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
name
Octavalent HPV with 120 mcg IMX / AAHS
other Names
V502
type
BIOLOGICAL
arm Group Labels
qHPV (GARDASIL™) - Phase A Control
qHPV (GARDASIL™) - Phase B Control
description
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
name
Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
other Names
V502-002
type
BIOLOGICAL

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: DOUBLE
who Masked: PARTICIPANT
INVESTIGATOR

primary Purpose

PREVENTION

Enrollment

count: 158
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
measure
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
time Frame
4 weeks postdose 3 (Phase A)
description
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
measure
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
time Frame
4 weeks postdose 3 (Phase B)
description
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
measure
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
time Frame
4 weeks postdose 3 (Phase A)
description
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
measure
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
time Frame
4 weeks postdose 3 (Phase B)

Full study description

brief Summary: This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.
detailed Description: The study was performed in 2 staggered phases, Phase A and Phase B. In Phase A, participants were randomized to qHPV, Octavalent HPV with 15 mcg IMX/AAHS, or Octavalent HPV with 30 mcg IMX/AAHS. After the safety for Phase A was reviewed, Phase B was initiated. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice