Seamless Controlled Trial To Evaluate Safety And Immunogenicity of Chikungunya Vaccine in LatinAmerica and Asia

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study has a Phase II with part A and part B and a Phase III with part C. This Adaptive seamless design will prospectively include planned modifications and incorporate both dose selection (parts A and B) and confirmation of the selected dose (part C) based on the accumulation of subjects' data within the entire study period as shown below. Part C will be randomized for immunogenicity subset and will be open label for safety cohort. The participants assigned to the control group from all parts (i.e, Part A, B and C) will be continuously followed up from the enrollment until the end of the study.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: International Vaccine Institute

Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, any individual must meet the following criteria:

1. Part A first component : Healthy participants 18 to 65 years of age at enrollment. Good health is based on medical history and physical examination Part A second component, Part B and Part C: Healthy participants 12 to 65 years of age at enrollment. Good health is based on medical history and physical examination

2. Participants/Parent(s)/LAR who have voluntarily signed and dated informed consent/assent based on local regulation. In case of a public health emergency in which site visits is not permitted, the informed consent can be obtained in accordance with the local IRB/EC or local regulatory agency guidelines.

3. Participants/Parent(s)/LAR who are able to attend all scheduled visits and to comply with all trial procedures Criteria applicable to women and adolescents of childbearing potential

4. Negative result on a pregnancy test (urine/serum) on day of enrollment before receiving study products.

5. Agree to use effective birth control^ methods (or abstinence) during the duration of the study.

• Adequate birth control is defined as follows, but not limited to: contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), and abstinence.

Note: If the subject during the pregnancy counseling process, answers yes to menopausal statuts with amenorrhea for at least 2 years, hysterectomy, or tubal ligation,therefore is not of childbearing potential.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Any current or pre-existing health conditions (e.g., any major congenital defects, etc) which in the opinion of the investigator may affect the safety of the subject or the study endpoints.

2. Participants concomitantly enrolled or scheduled to be enrolled in another trial

3. Any female participant who is lactating, pregnant* or planning for pregnancy** during the course of study period

4. History of rheumatoid arthritis and moderate or severe arthritis or arthralgia within past 90 days prior to Screening visit

5. Documented thrombocytopenia

6. Medical history of uncontrolled coagulopathy or blood disorders.

7. Medical history of seropositivity for Human Immunodeficiency Virus (HIV) infection.

8. Medical history or suspected congenital or acquired immune function disorders.

9. Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone or equivalent for periods exceeding 10 days within the past 3 months ), cytotoxic or other immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.

10. Receipt of blood or blood-derived products in the past 3 months

11. Individuals who received any other vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks of the study vaccine administration, except emergency vaccination after any dose.

12. Known history or allergy to vaccine components and excipients.

13. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives

14. Participants/Parent(s)/LAR planning to move from the study area before the end of study period

15. Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily (part of a vulnerable population).

16. Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures

17. As per Investigator's medical judgment individual could be excluded from the study in spite of meeting all inclusion/exclusion criteria mentioned above

18. Employee of the study center directly involved with the proposed study or with study investigators

Temporary Contraindication Should a subject experience one of the conditions/situations listed below, the Investigator will postpone/delay further vaccination until the condition/situation is resolved.

• Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator's judgment.

• Receipt of any vaccine in the 4 weeks preceding the trial vaccination.

• Lactation:This Investigational Product (IP) has not been specifically studied in pregnant and lactating women. No data on lactating women are available. There is no information about harm to an unborn child or a child who is breastfeeding. Breastfeeding women will not be enrolled. Should a female participant decide to breastfeed during the vaccination period, she will be excluded from further vaccination, but will be followed for safety until the end of the study

• Pregnancy Test ( serum/urine) is necessary for all female participants of childbearing age from menarche.

For pre-menarche females, the young female subjects will declare by themselves if they have not yet started menstruation. If a young female patient reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forward.