All-Trans Retinoic acid as an Oral Adjuvant

Retinoic acid as an oral adjuvant: is it generalisable and realistic?

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN89702061

Enrollment

100

Registered

2013-06-24

Start date

2013-06-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccine responses Infections and Infestations

Interventions

All-trans retinoic acid 10mg daily for 10 days against 20mg as single dose, using oral vaccines against typhoid, cholera, rotavirus, polio and enterotoxigenic E. coli. Second part of the study we wil

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Adult male volunteers, aged 18-60 from our community cohort in Misisi, Lusaka 2. Naïve to the vaccine to be administered 3. Children under 5 years of age, who will be included in the second part of the study only. In the second part of the study we will do some preliminary pharmacokinetics in children.

Exclusion criteria

Exclusion criteria: 1. Diarrhoea within the previous month 2. Antibiotics within the previous 2 weeks 3. Vaccination within the previous 6 months 4. Helminth infection 5. Ethanol dependency (i.e. the full clinical syndrome) 6. Inclusion in another research study

Design outcomes

Primary

Measure	Time frame
Specific sIgA secreted into gut lavage fluid directed against LPS and other vaccine antigens measured 14 days after vaccination	—

Secondary

Measure	Time frame
Changes in expression of alphabeta7-integrin, and changes of polymeric Ig receptor in small intestinal biopsies measured 14 days after vaccination	—

Countries

Zambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026