A Study of a New Leishmania Vaccine Candidate ChAd63-KH
Condition: Leishmaniasis, Cutaneous
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to assess the safety of a new candidate Leishmania vaccine ChAd63-KH in
      patients with persistent post kala azar dermal leishmaniasis (PKDL).

      This is a Phase II trial in patients with PKDL, to assess the safety and compare the humoral
      and cellular immune responses generated by the candidate vaccine in patients, and observe any
      clinical changes in the disease over a 42 day period following vaccination.

      Study design: Eight adult volunteers will receive 1x10(10)vp and the subsequent eight
      volunteers will receive 7.5 x10(10)vp. Adolescents will be vaccinated with either 1x10(10)vp
      or 7.5 x10(10)vp, to be determined by evaluation of all available data after DSMB & CTSC
      review.
    

Detailed description: 
      This is a study to assess the safety of a new candidate Leishmania vaccine ChAd63-KH in
      patients with persistent post kala azar dermal leishmaniasis (PKDL). With 95% of cases
      occurring in India, Bangladesh, Nepal, the Sudan and Brazil, visceral leishmaniasis (VL) is a
      disease of the poor. With an estimated 40,000 or more deaths annually, mostly children and
      young adults, VL ranks second only to malaria amongst parasitic infections for mortality, and
      as measured by DALYs lost, it ranks in the top ten infectious diseases globally. No effective
      vaccine has yet been developed for VL / PKDL despite significant research efforts.

      The investigators have recently completed a successful first-in-human clinical trial of a new
      therapeutic vaccine for VL / PKDL (ChAd63-KH). This trial demonstrated safety of ChAd63-KH in
      healthy UK adult volunteers and immunogenicity against the two Leishmania antigens on par
      with that seen to other vaccine candidate antigens in clinical development for other diseases
      (e.g. malaria, HCV, Ebola). Following external peer review of the data generated during
      LEISH1, the investigators have been awarded further Wellcome Trust funding to progress this
      vaccine into Phase II clinical trials in patients with PKDL.

      Study design: The first eight adult volunteers will receive 1x10(10)vp and, following DSMB
      and CTSC review, the subsequent eights adult volunteers will receive 7.5 x10(10)vp. Doses
      will be administered at a single time point. Adolescents will be vaccinated with either
      1x10(10)vp or 7.5 x10(10)vp, to be determined by evaluation of all available data after DSMB
      & CTSC review.

      Objectives:

        1. To assess the safety of a new candidate Leishmania vaccine ChAd63- KH in patients with
           persistent PKDL.

           Secondary objectives:

        2. To compare the humoral and cellular immune responses generated by the candidate vaccine
           in patients with persistent PKDL.

        3. To observe any clinical changes in the cutaneous PKDL disease over a 42 day period
           following vaccination.
    

Intervention name(s): ChAd63-KH
Intervention type(s): Drug
Intervention description(s): ChAd63-KH in adults and adolescents with persistent PKDL.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment