Safety and Immunogenicity of a Shigella-Tetravalent Bioconjugate Vaccine: A Phase 1/2 Randomized Controlled and Age Descending Study Including Dose Finding in 9 Month Old Infants

Trial Information
Who is this study for? Infants at risk for shigella
What treatments are being studied? Shigella 4V
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
Summary

In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old infants.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
8 months
Maximum Age:
50
Healthy Volunteers:
Accepts Healthy Volunteers

‣ All ages

• Healthy by medical history, laboratory findings and physical examination before entering into the study (Participants with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator)

• Seronegative for HIV, hepatitis B and C (as per screening laboratory tests)

• Resident in the study area village during the whole trial period (Kilifi -Kilifi Health and Demographic Surveillance System (Described in more detail in the SSA); (Kericho-a 75km radius from the Kericho Clinical Research Centre).

• Previously completed routine primary vaccinations (6,10 and 14 weeks or thereabouts) to the best knowledge of the participant/parent/guardian.

• Signed/thumb written informed consent, in accordance with local practice, provided by adult volunteers (participants 18 years of age and older), parents or legal representatives for children and infants participants as applicable, who, in the opinion of the investigator, can and will comply with the requirements of the protocol

• Demonstrated comprehension of the protocol procedures by passing score of 90% or better on a written/verbal comprehension test.

‣ Adults

• Female and male participants between, and including 18-50 years at the time of first vaccination

• Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. Female volunteers of childbearing potential may be enrolled in the study if the participant: has a negative urine pregnancy test at the day of screening and vaccinations, respectively, and

⁃ agree to use effective contraception for 30 days prior to vaccination and

⁃ agree to continue contraception at least for 2 months after completion of vaccination series.

‣ Children and Infants

• Female and male aged 9 months (+/- 1 month) old (infants) or between, and including, 2-5 years of age (children) at the time of the first vaccination

• Born full-term (i.e. after a gestation period of 37 to less than 42 completed weeks)

Where is this trial taking place?
Other Locations
Kenya
Kenya Medical Research Institute (KEMRI)/ United States Army Medical Research Directorate- Kenya (USAMRD-K)
Recruiting
Kericho
KEMRI-Centre Geographic Medical Research-COAST (KEMRI-CGMRC)
Recruiting
Kilifi
Who do I contact about this trial?
Primary
Mainga Hamaluba, MD
Mainga Hamaluba <MHamaluba@kemri-wellcome.org>
730 162110 ext 254
When is this trial taking place?
Start Date: September 2, 2019
Estimated Completion Date: July 2022
How many participants will be in this trial?
Target number of participants: 592
What treatment is being studied in this trial?
Experimental: NA (Non-adjuvanted) - very low dose - infants
Infants receive 3 very low doses of the non-adjuvanted investigational product
Experimental: A (adjuvanted) - very low dose - infants
Infants receive 3 very low doses of the adjuvanted investigational product
Experimental: NA (Non-adjuvanted) - low dose -infants
Infants receive 3 low doses of the non-adjuvanted investigational product
Experimental: A (adjuvanted) - low dose - infants
Infants receive 3 low doses of the adjuvanted investigational product
Experimental: NA (non-adjuvanted) - medium dose - infants
Infants receive 3 medium doses of the non-adjuvanted investigational product
Experimental: A (adjuvanted) - medium dose - infants
Infants receive 3 medium doses of the adjuvanted investigational product
Experimental: NA (non-adjuvanted) - medium dose - children
Children receive 3 medium doses of the non-adjuvanted investigational product
Experimental: A (adjuvanted) - medium dose - children
Children receive 3 medium doses of the adjuvanted investigational product
Experimental: NA (non-adjuvanted) - medium dose-adults
Adults receive 2 medium doses of the non-adjuvanted investigational product
Experimental: A (adjuvanted) - medium dose - adults
Adults receive 2 medium doses of the adjuvanted investigational product
Experimental: NA (non-adjuvanted) - high dose - infants
Infants receive 3 high doses of the non-adjuvanted investigational product
Experimental: A (adjuvanted) - high dose - infants
Infants receive 3 high doses of the adjuvanted investigational product
Experimental: NA (non-adjuvanted) - high dose - children
Chilldren receive 3 high doses of the non-adjuvanted investigational product
Experimental: A (adjuvanted) - high dose - children
Chilldren receive 3 high doses of the adjuvanted investigational product
Experimental: NA (non-adjuvanted) - high dose - adults
Adults receive 2 high doses of the non-adjuvanted investigational product
Experimental: A (adjuvanted) - high dose - adults
Adults receive 2 high doses of the adjuvanted investigational product
Experimental: MenACWY-Placebo
Adults receive one administration of MenACWY followed by one placebo administration
Other: Rabies
Children receive three administrations of Rabies
Other: MenACWY-DTaP
Infants receive two administrations of MenACWY followed by DTaP administration
Who are the authors of this trial?
What other conditions are being studied in this trial?

This content was sourced from clinicaltrials.gov