A Study of Safety, Tolerability and Immunogenicity of HPV-L2 Vaccine in Healthy Adult Male and Female Subjects

NCT03929172 | Completed Phase 1

• 2 other identifiers: 2AP01-012018-003045-42
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Papillomavirus Infections

Keywords

HPV-L2

Outcome Measures

Primary Outcomes (14)

• Percentage of Subjects Reporting Solicited Local Symptoms

  Solicited local symptoms assessed including pain, tenderness, redness, swelling, and induration.

  Day 0 and 1 after each vaccination

• Percentage of Subjects Reporting Solicited General Symptoms

  Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction.

  Through 365 days

• Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)

  An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study.

  Through 365 days

• Percentage of Subjects Reporting New Onset of Chronic Illness (NOCI)

  A NOCI is defined as diagnosis post study drug administration of a new medical condition, which is chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma)

  Through 365 days

• Percentage of Subjects Reporting Adverse Events of Special Interest (AESI)

  An AESI should not necessarily be classified to be a serious adverse event, even though the event may be clinically significant. If an AESI is reported, the Sponsor should be promptly informed and information relevant to the event should be promptly collected using the same process as that used for reporting serious adverse events. For this protocol, AESI includes demyelinating syndromes or neurological conditions such as complex regional pain or postural orthostatic tachycardia syndromes.

  Through 365 days

• Percentage of Subjects Reporting Serious Adverse Events (SAEs)

  SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

  Through 365 days

• Vital Signs - Body Temperature

  Single measurements of body temperature 35.6 ≤ Temperature ≤37.7 (C)

  Through 365 days

• Vital Signs - Respiratory Rate

  Measurements of respiratory rate 8≤ Respiration ≤24 (breaths/min)

  Through 365 days

• Vital Signs - Blood Pressure

  Measurements of blood pressure 90≤ Systolic ≤140 (mmHg) and 40≤ Diastolic ≤90 (mmHg

  Through 365 days

• Vital Signs - Heart Rate

  Measurements of 40≤ Pulse ≤99 (beats/min)

  Through 365 days

• Vital Signs - Body Mass Index (BMI

  Calculated as weight in kg / height in meters\^2

  Through 365 days

• Electrocardiogram (ECG)

  Single 12-lead ECGs will be performed. Measurement type must be one of the following: HR (50≤HR≤100 \[beats/min\]\], PR (110≤PR≤219 \[ms\]), QRS (QRS\<110 \[ms\]), QT, QTcF (QTcF for Male\<460 and for Female\<470 \[ms\]), or overall interpretation.

  Through 365 days

• Physical examination

  A full best practice physical examination will be performed by the PI

  Through 365 days

• Clinical Laboratory Tests

  Measurements of clinical laboratory abnormalities

  Through 365 days

Secondary Outcomes (2)

• Evaluation of immunogenicity using a humoral immune function ELISA assay from serum

  Through 365 days

• Evaluation of HPV-Neutralizing Antibodies using an in vitro Pseudovirion-Based HPV-Neutralization Assay (PBNA)

  Through 365 days

Study Arms (2)

AAVLP-HPV Vaccine Arm

EXPERIMENTAL

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).

Biological: AAVLP-HPV

Placebo Arm

PLACEBO COMPARATOR

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).

Drug: Placebo

Interventions

AAVLP-HPV BIOLOGICAL

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.

Also known as: 2AP01

AAVLP-HPV Vaccine Arm

Placebo DRUG

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.

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, adult, male or female aged between 18 and 45 years, inclusive, at screening.
• Body Mass Index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
• 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:
• hormonal oral contraceptives, vaginal ring, transdermal patch, or hormone releasing intrauterine device for at least 3 months prior to the first dosing with either a physical (e.g., condom, diaphragm, or other) or a chemical (e.g., spermicide) barrier method from the time of screening and throughout the study.
• depot/implantable hormone (e.g., Depo-provera®, Implanon) for at least 3 months prior to the first dosing and throughout the study.
• 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:
• hysteroscopic sterilization;
• bilateral tubal ligation or bilateral salpingectomy;
• hysterectomy;
• bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
• Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

You may not qualify if:

• Subjects must not be enrolled in the study if they meet any of the following criteria:
• Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
• History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
• History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
• Prior vaccination against HPV.
• Positive for HPV antibodies against HPV types 6, 11, 16, and 18.
• Have received an investigational vaccination within 90 days before screening.
• Have received any licensed vaccination within 30 days before screening.
• Any condition that may interfere with the intended administration of the study drug.
• Suffered from febrile or infectious illness within 7 days prior to Day 1.
• Subjects who plan to become pregnant/start a family during the study.
• Female subjects with a positive pregnancy test or who are lactating.
• Drink alcohol in excess of 21 glasses/units (425 g) per week for males or 14 glasses/units (284 g) per week for females, with one unit = 150 mL of wine or 360 mL of beer or 45 mL of 45% alcohol.

Sponsors & Collaborators

• 2A Pharma AB: lead
• Celerion: collaborator

Study Sites (1)

Celerion Inc.

Belfast, Co.Antrim, BT9 6AD, United Kingdom

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Nieland

  2A Pharma AB

  STUDY CHAIR

• David Bell

  Celerion, CRO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 26, 2019
• Study Start: February 28, 2019
• Primary Completion: May 29, 2020
• Study Completion: May 29, 2020
• Last Updated: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)