A Randomized, Observer-Blinded, Active-Controlled, Phase I Study to Evaluate the Safety and Immunogenicity of the Recombinant Zoster Vaccine (CHO Cell) in Healthy Adults Aged 40 Years and Older

Status: Completed

Location: See location...

Intervention Type: Biological

Study Type: Interventional

Study Phase: Phase 1

SUMMARY

This is a randomized, observer-blinded, active-controlled Phase I study to evaluate the safety, reactogenicity, and immunogenicity of REC610, when administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older, who do not have known HZ and history of varicella or HZ vaccination. The recombinant HZ vaccine, Shingrix® (GlaxoSmithKline), will be used as the active control.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 40

Healthy Volunteers: t

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• Male or female aged 40 years and older.

• Able and willing to comply with all study requirements.

• Willing to allow the investigators to discuss the volunteers' medical history with his/her general practitioner/personal doctors and access all medical records which are relevant to study procedures.

• Healthy adults, or adults with stable medical condition who have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.

Locations

Other Locations

Philippines

Pharma Peak Research Philippines,Inc.

Makati City

Time Frame

Start Date: 2023-02-09

Completion Date: 2023-12-06

Participants

Target number of participants: 48

Treatments

Experimental: REC610

Lyophilized gE antigen: white cake or powder. clear to opalescent, colorless liquid after reconstitution with water for injection BFA01 adjuvant suspension: opalescent white liquid After reconstitution: opalescent white liquid. Each dose (0.5 mL) contains 50 μg of Quillaja Saponin (QS-21), 50 μg of MPL, 1 mg of dioleoyl phosphatidylcholine, and 0.25 mg of cholesterol

Active_comparator: Shingrix

Lyophilized gE antigen: white cake or powder. clear to opalescent, colorless liquid after reconstitution with water for injection AS01B adjuvant suspension: opalescent, colorless to pale brownish liquid suspension After reconstitution: opalescent, colorless to pale brownish liquid. Each dose (0.5 mL) contains 50 μg of QS-21, 50 μg of MPL, 1 mg of dioleoyl phosphatidylcholine, and 0.25 mg of cholesterol

Related Therapeutic Areas

Chickenpox

Shingles

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A Randomized, Observer-Blinded, Active-Controlled, Phase I Study to Evaluate the Safety and Immunogenicity of the Recombinant Zoster Vaccine (CHO Cell) in Healthy Adults Aged 40 Years and Older

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