Safety and Immunogenicity of a Chlamydia Vaccine CTH522

PHASE1CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

February 17, 2020

Primary Completion Date

February 22, 2022

Study Completion Date

February 22, 2022

Conditions
Trachoma
Interventions
BIOLOGICAL

CTH522-CAF01 IM

On-site reconstitution of IMPs is performed by mixing 85 mcg CTH522 with CAF01. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 mL polypropylene Luer-Lok™ syringe via 23-25 gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.

BIOLOGICAL

CTH522-CAF09b IM

On-site reconstitution of IMPs is performed by mixing 85 mcg CTH522 with CAF09b. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 mL polypropylene Luer-Lok™ syringe via 23-25 gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.

BIOLOGICAL

CTH522 ID

24 mcg CTH522 given ID is in the non-dominant deltoid muscle. ID with a 1 mL syringe via a 26-28 gauge needle using a NanoPass device or similar. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.

BIOLOGICAL

CTH522 TO

24 mcg CTH522 (12 mcg in each eye) TO administrations will be performed using a Gilson positive displacement pipette. The identity of vaccine will be known to the clinical site staff dispensing/administrating the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.

BIOLOGICAL

Placebo (Saline)

Placebo only given as IM, ID and TO.

Trial Locations (1)

W12

NIHR Imperial Center for Translational and Experimental Medicine, London

All Listed Sponsors
collaborator

Imperial College London

OTHER

lead

Statens Serum Institut

OTHER

NCT03926728 - Safety and Immunogenicity of a Chlamydia Vaccine CTH522 | Biotech Hunter | Biotech Hunter