Condition or disease | Intervention/treatment | Phase |
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Papillomavirus Infections | Biological: AAVLP-HPV Drug: Placebo | Phase 1 |
2A Pharma's AAVLP-HPV vaccine candidate is based on AAVLPs with insertion of sequences of the L2 minor HPV capsid protein. The vaccine's intended clinical use is as a vaccine for prophylaxis against HPV infection in adolescents and adults.
This is a 12 month single-center, randomized, placebo-controlled, double-blind, repeated dose, safety, tolerability, and immunological effect study. Twenty (20) healthy, adult male and female subjects will be enrolled with a minimum of 40% of each gender. Sixteen (16) subjects will be randomized to receive the active drug and 4 subjects to receive the placebo. At least 1 subject of each gender will be randomized to receive the placebo.
Subjects will receive a total of 3 doses of AAVLP-HPV or placebo: a prime on Day 1, and two boosts, one on Day 57 (±2 days) and one on Day 180 (±1 week). The volunteers will be followed until day 365 (±1 week) when they return for the final safety and serum-based immunogenicity and neutralising antibodies assessment.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A First-in-Human, Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety and Tolerability, and to Explore Immunological Effects of I.M. Administered AAVLP-HPV Vaccine in Healthy Adult Male and Female Subjects |
Actual Study Start Date : | February 28, 2019 |
Actual Primary Completion Date : | May 29, 2020 |
Actual Study Completion Date : | May 29, 2020 |
Arm | Intervention/treatment |
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Experimental: AAVLP-HPV Vaccine Arm
Subjects will receive a total of 3 vaccinations: a prime on Day 1, and boosts on Day 57 (± 2 days) and Day 180 (± 1 week).
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Biological: AAVLP-HPV
20μg/injection formulated in a ready to use solution containing 100mM sodium citrate, 2.5 mM MgCl2, 0.001% pluronic F-68, pH 6.0 for i.m. injection as 0.5 mL per injection.
Other Name: 2AP01
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Placebo Comparator: Placebo Arm
Subjects will receive a total of 3 vaccinations: a prime on Day 1, and boosts on Day 57 (± 2 days) and Day 180 (± 1 week).
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Drug: Placebo
0.5 mL 100 mM Sodium Citrate, 2.5 mM MgCl2, 0.001% Pluronic F-68, pH 6 for i.m. injection as 0.5 mL per injection.
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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
For a female of childbearing potential: either be sexually inactive (abstinent as a lifestyle*) for 28 days prior to the first dosing and throughout the study or be using one of the following acceptable birth control methods:
In addition, female subjects of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 28 days following the last dose.
* True abstinence is defined as refraining from heterosexual intercourse in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study drug, and withdrawal are not acceptable methods of contraception.
For a female of non-childbearing potential: must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
Exclusion Criteria:
Subjects must not be enrolled in the study if they meet any of the following criteria:
United Kingdom | |
Celerion Inc. | |
Belfast, Co.Antrim, United Kingdom, BT9 6AD |
Study Chair: | John Nieland | 2A Pharma AB | |
Principal Investigator: | David Bell | Celerion, CRO |
Tracking Information | |||||||
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First Submitted Date ICMJE | April 12, 2019 | ||||||
First Posted Date ICMJE | April 26, 2019 | ||||||
Last Update Posted Date | July 1, 2020 | ||||||
Actual Study Start Date ICMJE | February 28, 2019 | ||||||
Actual Primary Completion Date | May 29, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study of Safety, Tolerability and Immunogenicity of HPV-L2 Vaccine in Healthy Adult Male and Female Subjects | ||||||
Official Title ICMJE | A First-in-Human, Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety and Tolerability, and to Explore Immunological Effects of I.M. Administered AAVLP-HPV Vaccine in Healthy Adult Male and Female Subjects | ||||||
Brief Summary | The purpose of this study is to evaluate the safety, tolerability, and the immunological effects of adeno-associated virus-like particle human papillomavirus (AAVLP-HPV) vaccine in healthy adults. | ||||||
Detailed Description |
2A Pharma's AAVLP-HPV vaccine candidate is based on AAVLPs with insertion of sequences of the L2 minor HPV capsid protein. The vaccine's intended clinical use is as a vaccine for prophylaxis against HPV infection in adolescents and adults. This is a 12 month single-center, randomized, placebo-controlled, double-blind, repeated dose, safety, tolerability, and immunological effect study. Twenty (20) healthy, adult male and female subjects will be enrolled with a minimum of 40% of each gender. Sixteen (16) subjects will be randomized to receive the active drug and 4 subjects to receive the placebo. At least 1 subject of each gender will be randomized to receive the placebo. Subjects will receive a total of 3 doses of AAVLP-HPV or placebo: a prime on Day 1, and two boosts, one on Day 57 (±2 days) and one on Day 180 (±1 week). The volunteers will be followed until day 365 (±1 week) when they return for the final safety and serum-based immunogenicity and neutralising antibodies assessment. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Papillomavirus Infections | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
20 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | May 29, 2020 | ||||||
Actual Primary Completion Date | May 29, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
Exclusion Criteria: Subjects must not be enrolled in the study if they meet any of the following criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 45 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United Kingdom | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03929172 | ||||||
Other Study ID Numbers ICMJE | 2AP01-01 2018-003045-42 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | 2A Pharma AB | ||||||
Study Sponsor ICMJE | 2A Pharma AB | ||||||
Collaborators ICMJE | Celerion | ||||||
Investigators ICMJE |
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PRS Account | 2A Pharma AB | ||||||
Verification Date | June 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |