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Typhoid FeverPhase 4TyVEGHANCT04852185

Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana

A Phase 4 study testing Vi-TT and MCV-A vaccine in people with Typhoid Fever, run by International Vaccine Institute at 1 site in Ghana.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA) with a primary endpoint of determining the total protection conferred by single-dose vaccination with Vi-TT against blood culture-confirmed… Read more about this study

Who is it for?
Ages 9 months to 15 yearsHealthy volunteers can take part
Conditions the study is for
Typhoid Fever
What is being tested?
Vi-TT and MCV-A vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23,000 participants
Where
1 siteGhana
Study dates
24 Aug 2021to 31 Dec 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 months to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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

  • Healthy participants aged 9 months to <16 years (i.e., ≤15 years and 364 days) of age at the time of vaccination
  • Participants/Parents/legally authorized representative (LAR) who have voluntarily given informed assent (sought from participants aged 12 years to <16 years) and informed consent
  • Participants/Parents/LAR living within study target area at the time of vaccination and willing to follow the study procedures and be available for the entire duration of the study

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

  • Known allergy to any vaccine component
  • Self-reported ongoing acute and/or chronic illness
  • Any self-reported coagulopathies
  • Any medical or social compelling reasons in the judgment of a clinical physician
  • Self-reported pregnancy/Positive urine pregnancy test or lactating
  • Previous typhoid vaccination in the last 5 years (proven by the presentation of a vaccine card or self-reporting).

Temporary exclusion criteria

  • Self-reported fever (elevated tympanic (≥38°C) or axillary temperature (≥37.5°C)) within 24 hours of vaccination
  • Self-reported use of antipyretics within 4hours prior to vaccination
  • Any other vaccination during the last 4 weeks (proven by the presentation of a vaccine card or self-reporting)
  • Girls ≥11 years of age with self-reported irregular menstruation or who do not know their last menstruation date

Trial locations and contacts

1 site in 1 country.

Birkneh T Tadesse, PhD contact

+821098041348

birkneh.tadesse@ivi.int

Thaint Thaint Thwe, MBBS, MSc. contact

+821037907535

ThaintThaint.Thwe@ivi.int

Ghana1 site, 1 recruiting

  • Kwame Nkrumah University of Science and Technology

    Kumasi, Ashanti Region, PMB

    Ellis Owusu Dabo, PhD, +233201964425, owusudabo@yahoo.com

    Recruiting

Other trials in Ghana

About this study

Official title: A Cluster-randomised Controlled Phase IV Trial Assessing the Impact of a Vi-Polysaccharide Conjugate Vaccine in Preventing Typhoid Infection in Asante Akim, Ghana (TyVEGHA)

A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA) with a primary endpoint of determining the total protection conferred by single-dose vaccination with Vi-TT against blood culture-confirmed symptomatic S. Typhi infection in the intervention vaccine clusters, compared with the control vaccine clusters.

Read the detailed description

Typhoid fever remains a significant health problem in sub-Saharan Africa, with incidence rates >100 cases per 100,000 person-years of observation. Despite the prequalification of safe and effective typhoid conjugate vaccines (TCV), the uptake of these vaccines in African countries has remained low. Real-life effectiveness data, which inform public health programs on the impact of TCVs in reducing typhoid-related mortality and morbidity, are critical to enhancing the introduction of TCVs in high-burden settings. Here we describe a cluster-randomized trial to investigate population-level protection of TCV against blood culture-confirmed typhoid fever. A total of 80 geographically distinct clusters have been delineated within the Agogo district of the Asante Akim region in Ghana. Clusters will be randomized to the intervention arm receiving TCV or a control arm receiving the meningococcal A conjugate vaccine. The primary study endpoint is the overall protection of TCV against blood culture-confirmed typhoid fever. Total, direct, and indirect protection will be measured as secondary outcomes. Blood culture-based enhanced surveillance will enable the estimation of incidence rates in the intervention and control clusters. Evaluation of the real-world impact of TCVs will improve uptake of prequalified/licensed safe and effective typhoid vaccines in public health programs of high burden settings.

Conditions
Typhoid Fever
Being tested
Vi-TT, MCV-A vaccine
Keywords
Typhoid, Typhoid conjugate vaccine, Cluster randomised trial
Medical subject headings
Typhoid Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vi-TTBiological

    Single-dose V-TT administered to children and adolescents between the ages of 9 months to 15 years.

  • MCV-A vaccineBiological

    Single-dose of MCV-A vaccine (a meningococcal vaccine)

Study groups in NCT04852185
Study groupRoleWhat they receive
Vi-TT ArmExperimentalA single dose of Vi-TT to children 9 months to 15 years of age.
Receives: Biological: Vi-TT
MCV-A armActive comparatorA single dose of MCV-A vaccine to the comparator group.
Receives: Biological: MCV-A vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Protection

    The incidence of blood culture-confirmed symptomatic TF in all vaccine recipients of the intervention clusters, compared with control clusters.

    Measured: 3 years

Secondary outcomes (8)

  1. Safety Assessment

    1. Proportion of adverse events in participants receiving Vi-TT compared with MCV-A, measured by:
    • The proportion of participants in each group of a sub-sample of the cohort developing adverse events/adverse reactions within the first 7 days post-vaccination.
    • The proportion of participants in each group of the cohort developing serious adverse events during the entire study period, as determined by self-reporting at follow-up contact.

    Measured: 3 years

  2. Overall protection

    The incidence of blood culture-confirmed symptomatic TF in all residents of the intervention clusters compared with that in all residents of control clusters

    Measured: 3 years

  3. Total protection against severe typhoid.

    The incidence of severe TF in vaccinated individuals in intervention clusters compared to control clusters

    Measured: 3 years

  4. Total protection against clinical typhoid.

    The incidence of clinical typhoid fever cases, defined as persistent fever (tympanic (≥38.0℃) or axillary temperature (≥37.5℃) or reported fever for ≥3 consecutive days) with abdominal complaints at a study surveillance site in vaccinated individuals in intervention clusters compared to control clusters.

    Measured: 3 years

  5. Overall protection against clinical typhoid.

    The incidence of clinical typhoid fever cases presenting at a study surveillance site among all residents of the Vi-TT clusters compared to the control vaccine clusters.

    Measured: 3 years

  6. Indirect Protection aganist Blood Culture Confirmed Typhoid.

    The incidence of blood culture-confirmed symptomatic TF in non-vaccinees of the intervention clusters compared with control clusters.

    Measured: 3 years

  7. Seroconversion rates

    The seroconversion rates as measured by enzyme linked immunosorbent assay (anti-Vi IgM and IgG) for S. Typhi and iNTS at defined time points in a age-stratified subset of intervention and control vaccinees.

    Measured: 3 years

  8. Geometric mean titers

    The antibody concentration as measured by enzyme linked immunosorbent assay (anti-Vi IgM and IgG) for S. Typhi and iNTS at defined time points in a age-stratified subset of intervention and control vaccinees.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2021
  2. Study start24 Aug 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participant- and observer-blinded, cluster-randomised controlled Phase IV trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
23,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04852185
Sponsor's protocol ID
TyVEGHA2020
Acronym
TyVEGHA
Status last verified
Mar 2024
First submitted
17 Mar 2021
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Sharing can be considered on a case-by-case basis considering the intended use and impact.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vi-TT and MCV-A vaccine in people with Typhoid Fever, run by International Vaccine Institute at 1 site in Ghana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Birkneh T Tadesse, PhD (+821098041348, birkneh.tadesse@ivi.int), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Protection (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04852185.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.

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