Phase 2 N=383 Randomized Double-blind Prevention

Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

Infections, Papillomavirus

Bottom Line

View on ClinicalTrials.gov: NCT00231413 ↗

Enrolled (actual)

383

Serious AEs

2.6%

Results posted

Dec 2019

Primary outcome: Primary: Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7 — 62; 27; 31; 23 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: HPV 16/18 L1 AS04 (Biological); HPV-16/18/31/45 L1 AS04 Formulation 1 (Biological); HPV-16/18/31/45 L1 AS04 Formulation 2 (Biological); HPV-16/18/31/45 L1 AS04 Formulation 3 (Biological); HPV-16/18/31/45 L1 AS04 Formulation 4 (Biological); HPV-16/18/31/45 L1 AS04 Formulation 5 (Biological); HPV-16/18/31/45 L1 AS04 Formulation 6 (Biological)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: GlaxoSmithKline
Primary completion: Mar 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7	62; 27; 31; 23; 33; 28	—
PRIMARY Number of Seroconverted Subjects for Anti-HPV-18 at Month 7	59; 30; 37; 34; 27; 33	—
PRIMARY Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7	9086.1; 5757.4; 7897.7; 7524.1; 5986.4; 8483.5	—
PRIMARY Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7	5184.5; 3061.3; 3640.2; 3268.6; 2998.5; 3296.2	—
SECONDARY Number of Seroconverted Subjects for Anti-HPV-16 at Month 2	62; 27; 31; 23; 33; 28	—
SECONDARY Number of Seroconverted Subjects for Anti-HPV-18 at Month 2	59; 30; 37; 34; 27; 33	—
SECONDARY Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2	3256.7; 2718.9; 2779.4; 2915.5; 2353.5; 3202.3	—
SECONDARY Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2	2530.1; 1731.5; 1875.9; 2082.2; 2048.8; 2003.1	—
SECONDARY Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7	54; 32; 37; 29; 31; 30	—
SECONDARY Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7	54; 33; 31; 27; 32; 34	—
SECONDARY Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7	232.8; 3694.6; 6271.3; 4570.7; 5114.8; 4846.7	—
SECONDARY Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7	317.4; 1550.7; 2613.9; 1893.7; 2113.3; 2217.4	—
SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms	81; 45; 44; 45; 44; 49	—
SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	6; 6; 4; 6; 10; 5	—
SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	60; 31; 34; 25; 32; 36	—
SECONDARY Number of Subjects With Any Serious Adverse Events (SAEs)	1; 2; 0; 2; 1; 0	—
SECONDARY Number of Subjects With Any SAEs During the Extended Safety Follow-up	2; 2; 1; 3; 2; 0	—
SECONDARY Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	0; 0; 2; 1; 0; 1	—
SECONDARY Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	5; 1; 6; 1; 3; 1	—
SECONDARY Number of Subjects Reporting Medically Significant Conditions	2; 1; 1; 2; 2; 0	—
SECONDARY Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters	78; 43; 42; 44; 42; 47	—

Summary

Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.

Eligibility Criteria

Inclusion Criteria

A woman between, and including, 18 and 25 years of age at the time of the first vaccination
Written informed consent from the subject prior to enrolment
Subject must be free of obvious health problems
Subject must be of non-childbearing potential and have had no more than 6 lifetime sexual partners

Exclusion Criteria

Pregnant or breastfeeding
A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality
History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease
Previous vaccination against human papillomavirus (HPV)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00231413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.