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TyphoidPhase 2NCT07624175

Immunogenicity and Tolerability of Booster Typhoid Conjugate Vaccine (TCV) 5-6 Years After Initial Dose in Children in Burkina Faso

A Phase 2 study testing Vi capsular polysaccharide-CRM197 conjugate vaccine (Vi-CRM), 0.5 mL IM in people with Typhoid, run by Kathleen Neuzil at 1 site in Burkina Faso.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluated the persistence of immunity following primary typhoid conjugate vaccination in early childhood and assessed the immunogenicity and safety of a booster dose administered 5-6 years later. Read more about this study

Who is it for?
Ages 6 to 7 yearsHealthy volunteers can take part
Conditions the study is for
Typhoid
What is being tested?
Vi capsular polysaccharide-CRM197 conjugate vaccine (Vi-CRM), 0.5 mL IM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
1 siteBurkina Faso
Study dates
17 Aug 2024to 26 Oct 2024
Phase
Phase 2
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 6 to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Male or female children previously enrolled in the 2018-2019 Phase 2 typhoid conjugate vaccine trial
  • Residence within study area
  • Parent/guardian provides informed consent

Who cannot join

  • Receipt of blood products within 6 months
  • Prior typhoid conjugate vaccine receipt outside the study
  • Medical condition interfering with evaluation
  • Acute illness or fever prior to vaccination (temporary exclusion)

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

  • Schiphra Protestant Hospital

    Ouagadougou

Other trials in Burkina Faso

About this study

Official title: Immunogenicity and Tolerability of Typhoid Conjugate Vaccine (TCV) 5-6 Years After Routine Vaccines Administered With or Without TCV Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso

This study evaluated the persistence of immunity following primary typhoid conjugate vaccination in early childhood and assessed the immunogenicity and safety of a booster dose administered 5-6 years later. Children previously enrolled in a Phase 2 randomized clinical trial of Vi-tetanus toxoid conjugate vaccine (Vi-TT) were re-enrolled at 6-7 years of age. Participants who previously received Vi-TT received a booster dose of Vi-CRM, while control participants received their first TCV dose.

Anti-Vi IgG antibody responses were measured at baseline and 28 days post-vaccination. Safety was assessed through solicited and unsolicited adverse events. This study provides data on durability of TCV immunity and the potential role of booster dosing in endemic settings.

Read the detailed description

This prospective, open-label interventional study followed children previously enrolled in a Phase 2 randomized controlled trial of Vi-TT administered in infancy. Approximately 5-6 years later, participants were re-contacted and assigned to receive either a booster TCV dose (Vi-CRM) or a first TCV dose depending on prior vaccination status.

Immunogenicity was assessed using anti-Vi IgG ELISA assays at baseline and 28 days post-vaccination. Safety outcomes included solicited and unsolicited adverse events and serious adverse events. The study was conducted at a single clinical site in Ouagadougou, Burkina Faso.

Conditions
Typhoid
Being tested
Vi capsular polysaccharide-CRM197 conjugate vaccine (Vi-CRM), 0.5 mL IM
Keywords
typhoid vaccine, Salmonella Typhi, typhoid fever
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 capsular polysaccharide-CRM197 conjugate vaccine (Vi-CRM), 0.5 mL IMBiological

    Typhoid conjugate vaccine: Vi capsular polysaccharide conjugated to CRM197 carrier protein, administered as 0.5mL intramuscularly

Study groups in NCT07624175
Study groupRoleWhat they receive
typhoid conjugate vaccine (TCV)ExperimentalReceived one intramuscular dose of Vi-CRM (TYPHIBEV®)
Receives: Biological: Vi capsular polysaccharide-CRM197 conjugate vaccine (Vi-CRM), 0.5 mL IM

What is being measured

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

  1. Anti-Vi IgG Antibody Response (Immunogenicity)

    Geometric Mean Titers (GMT) and fold-rise in anti-Vi IgG

    Measured: Baseline (Day 0) and Day 28 post-vaccination

Secondary outcomes (4)

  1. Seroconversion rate

    Proportion of participants achieving ≥4-fold increase in anti-Vi IgG

    Measured: Day 28

  2. Solicited adverse events

    Local and systemic adverse events within 7 days post-vaccination

    Measured: Days 0-7

  3. Unsolicited adverse events

    Any non-solicited adverse events

    Measured: Days 0-28

  4. Serious adverse events

    Any serious adverse events

    Measured: Days 0-28

Timeline

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

  1. First posted3 Jun 2026
  2. Study start17 Aug 2024
  3. Primary completion26 Oct 2024
  4. Study completion26 Oct 2024

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Participants vaccinated previously at age 9-23 months with either typhoid conjugate vaccine (Vi-TT typhoid conjugate vaccine) or control vaccine (inactivated polio vaccine) as part of a clinical trial receive a dose of typhoid conjugate vaccine (Vi-CRM typhoid conjugate vaccine) as a first or second typhoid conjugate vaccine dose, respectively.
Masking
None (open label)
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07624175
Sponsor's protocol ID
HP-00110239
Other IDs
INV 030857
Status last verified
May 2026
First submitted
28 May 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data will be available, after de-identification, via the Vivli platform upon approved request.

Publications

  • Laurens MB, Sirima SB, Rotrosen ET, Siribie M, Tiono A, Ouedraogo A, Liang Y, Jamka LP, Kotloff KL, Neuzil KM. A Phase II, Randomized, Double-blind, Controlled Safety and Immunogenicity Trial of Typhoid Conjugate Vaccine in Children Under 2 Years of Age in Ouagadougou, Burkina Faso: A Methods Paper. Clin Infect Dis. 2019 Mar 7;68(Suppl 2):S59-S66. doi: 10.1093/cid/ciy1104.

    PubMed 30845330

  • Sirima SB, Ouedraogo A, Barry N, Siribie M, Tiono AB, Nebie I, Konate AT, Berges GD, Diarra A, Ouedraogo M, Soulama I, Hema A, Datta S, Liang Y, Rotrosen ET, Tracy JK, Jamka LP, Neuzil KM, Laurens MB. Safety and immunogenicity of co-administration of meningococcal type A and measles-rubella vaccines with typhoid conjugate vaccine in children aged 15-23 months in Burkina Faso. Int J Infect Dis. 2021 Jan;102:517-523. doi: 10.1016/j.ijid.2020.10.103. Epub 2020 Nov 8.

    PubMed 33176205

  • Sirima SB, Ouedraogo A, Barry N, Siribie M, Tiono A, Nebie I, Konate A, Berges GD, Diarra A, Ouedraogo M, Bougouma EC, Soulama I, Hema A, Datta S, Liang Y, Rotrosen ET, Tracy JK, Jamka LP, Oshinsky JJ, Pasetti MF, Neuzil KM, Laurens MB. Safety and immunogenicity of Vi-typhoid conjugate vaccine co-administration with routine 9-month vaccination in Burkina Faso: A randomized controlled phase 2 trial. Int J Infect Dis. 2021 Jul;108:465-472. doi: 10.1016/j.ijid.2021.05.061. Epub 2021 Jun 1.

    PubMed 34082090

  • Ouedraogo A, Diarra A, Nebie I, Barry N, Kabore JM, Tiono AB, Datta S, Liang Y, Mayo I, Oshinsky JJ, Tracy JK, Girmay T, Pasetti MF, Jamka LP, Neuzil KM, Sirima SB, Laurens MB. Durable Anti-Vi IgG and IgA Antibody Responses in 15-Month-Old Children Vaccinated With Typhoid Conjugate Vaccine in Burkina Faso. J Pediatric Infect Dis Soc. 2023 Sep 27;12(9):513-518. doi: 10.1093/jpids/piad058.

    PubMed 37589596

  • Sawadogo JW, Hema A, Diarra A, Kabore JM, Hien D, Kouraogo L, Zou AR, Ouedraogo AZ, Tiono AB, Datta S, Pasetti MF, Neuzil KM, Sirima SB, Ouedraogo A, Laurens MB#. Immunogenicity and tolerability of booster typhoid conjugate vaccine (TCV) five to six years after initial dose in Burkinabe children. medRxiv [Preprint]. 2026 Apr 21. doi:10.64898/2026.04.19.26351224.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vi capsular polysaccharide-CRM197 conjugate vaccine (Vi-CRM), 0.5 mL IM in people with Typhoid, run by Kathleen Neuzil at 1 site in Burkina Faso.

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

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 3 Jun 2026. 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 Burkina Faso. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-Vi IgG Antibody Response (Immunogenicity) (time frame: Baseline (Day 0) and Day 28 post-vaccination). 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 NCT07624175, which also lists 5 linked publications.

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 3 Jun 2026.

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