Immunogenicity Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

Cervical Cancer Clinical Trial

Official title:

An Randomized, Double-Blinded, Placebo Controlled Phase II Clinical Trial to Estimate Immunogenicity of the Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type) (E.Coli) in Healthy Adults Aged 18 to 45 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03935204
• Other study ID #: HPV-PRO-008
• Status: Completed
• Phase: Phase 2
• Start date: May 13, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II clinical study was designed to evaluate the immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 627
• Est. completion date: April 1, 2021
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Health women aged between 18 and 45 years.

2. Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.

3. Able to comply with the requests of the study.

4. Written informed consent obtained from the participants.

5. Axillary temperature not higher than 37.0°C

6. Non-pregnant women verified by a urine pregnancy test.

Exclusion Criteria:

1. Pregnant or breastfeeding or plan to be pregnant within 7 months.

2. Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.

3. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.

4. Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine or plan to use within 7 months.

5. Administration of any attenuated live vaccines within 21 days preceding the first dose of the study vaccine or any subunit or inactivated vaccines within 14 days before vaccination.

6. Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.

7. Having the plan to participate another clinical trial during the study period.

8. Received another HPV vaccine.

9. Immunodeficiency , primary disease of important organs, malignant tumor, or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).

10. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy, urticaria, dyspnea, angioneurotic edema or abdominal pain.

11. Asthma that required emergent treatment, hospitalization, oral or intravenous corticosteroid for unstable condition within the past 2 years.

12. Having serious disease of internal medicine, such as hypertension, cardiac disease, diabetes, hyperthyroidism et al.

13. Diagnosed coagulant function abnormality or blood coagulation disorder.

14. Epilepsy, except fever epilepsy at under 2 years of age, alcohol-induced epilepsy in 3 years before abstinence, or idiopathic epilepsy requiring no treatment in the past 3 years.

15. Past or current two-stage affective psychosis, not well controlled in the past 2 years or requiring drugs, or hve a tendency to commit suicide in the past 5 years.

16. Other medical, psychological, social or occupational factors that, according to the investigators' judgment, might affect the individual's ability to obey the protocol or sign the informed consent.

Related Conditions & MeSH terms

• Cervical Cancer
• Condylomata Acuminata
• Uterine Cervical Neoplasms

Intervention

Biological:
• HPV Vaccine,270µg/1.0ml
HPV vaccine (270µg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
• Placebo
Aluminium adjuvant (1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Locations

Country	Name	City	State
China	Jiangsu Provincial Centre for Disease Control and Prevention	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Xiamen University	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Xiamen Innovax Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody)	To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific IgG antibody level on day 0 (before the 1st dose) and one month after dose 3	month 7
Other	Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations in a immunogenicity subgroup at Months 1,2 and 7 (type specific neutralizing antibody and IgG antibody)	To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing and IgG antibody level of a immunogenicity subgroup at month 1,2 and 6.	month 1,2 and 6
Primary	Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody)	To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level on day 0 (before the 1st dose) and one month after dose 3	month 7
Secondary	Solicited local adverse reactions	Solicited local adverse reactions occurred within 7 days after each vaccination;	During the 7-day (Day 0-6) period following each vaccination
Secondary	Solicited systematic adverse reactions	Solicited systematic adverse reactions occurred within 7 days after each vaccination;	During the 7-day (Day 0-6) period following each vaccination
Secondary	Unsolicited adverse events	Unsolicited adverse reactions occurred within 30 days after each vaccination;	Within 30 days (Day 0-29) after any vaccination
Secondary	Serious adverse events	Serious adverse events occurred throughout the study;	throughout the study period, an average of 7 months