# First-in-Human Trial of the Novel Tuberculosis Vaccine Candidate, H107e/CAF®10b

> **NCT06050356** · PHASE1 · ACTIVE_NOT_RECRUITING · sponsor: **Statens Serum Institut** · enrollment: 140 (estimated)

## Conditions studied

- Healthy

## Interventions

- **BIOLOGICAL:** H107e
- **BIOLOGICAL:** CAF®10b
- **BIOLOGICAL:** H107e/CAF®10b - low adjuvant dose
- **BIOLOGICAL:** H107e/CAF®10b - full adjuvant dose
- **BIOLOGICAL:** Low dose intranasal H107e
- **BIOLOGICAL:** Full dose intranasal H107e
- **BIOLOGICAL:** H107e/CAF®10b
- **BIOLOGICAL:** i.m. placebo
- **BIOLOGICAL:** BCG
- **BIOLOGICAL:** i.d. placebo
- **BIOLOGICAL:** Intranasal H107e

## Key facts

- **NCT ID:** NCT06050356
- **Lead sponsor:** Statens Serum Institut
- **Sponsor class:** OTHER
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2024-03-14
- **Primary completion:** 2026-12
- **Final completion:** 2026-12
- **Target enrollment:** 140 (ESTIMATED)
- **Last updated:** 2026-03-10

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06050356

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06050356, "First-in-Human Trial of the Novel Tuberculosis Vaccine Candidate, H107e/CAF®10b". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT06050356. Licensed CC0.

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