None listed
Conditions
Brief summary
Human papilloma virus (HPV) vaccines have the potential to significantly reduce the problem of cervical cancer and a number of countries have recommended their routine administration. This single blind randomised study will compare two HPV vaccines administered by two different routes (intra-muscularly and intradermally) in different doses. The study aims to demonstrate that a reduced dose of vaccine given intradermally is not inferior in terms of protective antibody response (immunogenicity) to a full dose of vaccine given intra-muscularly. Following an initial reactogenicity study of 10 male subjects, a total of 40 female subjects aged 18 to 26 years will be recruited. As the intradermal route has the potential for easier and safer administration of vaccines, at significantly reduced cost, there is the potential for this study to have significant global implications in terms of making these newer, and relatively expensive, vaccines more widely available.
Interventions
A total of 40 female subjects aged 18-26y at the start of the study will be enrolled. After consent, all subjects will have blood taken for serum antibody to HPV16 and HPV18. Those subjects who test negative for both HPV16 and HPV18 will be randomised, using simple randomisation. Subjects will be vaccinated on Day 1, Month 2 (+/- 2 weeks) and Month 6 (+/- 2 weeks). Five subjects for each vaccine type will receive full dose (0.5ml) intramuscularly, five will receive 20% (0.1ml) of the full dose i
A total of 40 female subjects aged 18-26y at the start of the study will be enrolled. After consent, all subjects will have blood taken for serum antibody to HPV16 and HPV18. Those subjects who test negative for both HPV16 and HPV18 will be randomised, using simple randomisation. Subjects will be vaccinated on Day 1, Month 2 (+/- 2 weeks) and Month 6 (+/- 2 weeks). Five subjects for each vaccine type will receive full dose (0.5ml) intramuscularly, five will receive 20% (0.1ml) of the full dose intramuscularly, five will receive a 20% (0.1ml) of full dose intradermally via an intradermal injection device, and five will receive 20% (0.1ml) of full dose intradermally with a tuberculin syringe and needle for all three vaccine doses. An equal number of subjects will receive Gardasil and Cervarix. As this study involves three clearly identifiable routes of administration for the two vaccines, this will not be a double-blind study. Prior to starting the main study a 20%-dose of Cervavix vaccine (0.1-ml) and a 20%-dose of Gardasil vaccine (0.1-ml) will each be given intradermally via syringe and needle to ten adult males with 5 subjects receiving each vaccine to ensure that no unexpectedly severe reactions occur with the Cervavix vaccine which contains a novel adjuvant (ASO4) that has not been administered intradermally before and could be more reactogenic than vaccines such as Gardasil containing traditional alum adjuvants. Subjects in this reactogenicity assessment will complete Diary Cards, undergo two blood tests and photographs of the skin reactions will be taken.
Sponsors
The Chinese University of Hong Kong
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Female subjects will be eligible to participate in the study if they: 1. Are 18-26 years of age at the start of the study; 2. Participants have an understanding of the study, agree to its requirements, and give written informed consent prior to study entry; 3. Are generally healthy; 4. Agree to keep a record of symptoms for 14 days after each vaccination; 5. Are sexually naive.
Exclusion criteria
1. Have previously received HPV vaccine 2. Test positive for either HPV 16/18 serum antibody at enrolment; 3. Are not sexually naive at enrollment; 4. Do not agree to use effective contraception if become sexually active; 5. Are allergic to any vaccine component 6. Have received blood products or components during the previous 6-months 7. Have any known immune or coagulation disorder 8. Received any inactivated vaccine product within the 14 days before enrolment 9. Received any live vaccine product within 21 days before enrolment.
Outcome results
None listed