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Immunogenicity and reatogenicity of Hepatitis B vaccine derived from Hansenula polymorpha compared to Saccharomyces cerevisiae in men deprived of their liberty

Immunogenicity and reatogenicity of Hepatitis B vaccine derived from Hansenula polymorpha compared to Saccharomyces cerevisiae in men deprived of their liberty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-27bn6z
Enrollment
Unknown
Registered
2020-02-26
Start date
2017-10-07
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Hepatitis B

Interventions

Experimental group: 50 individuals. Administration of hepatitis B vaccine, recombinant EUVAX B manufactured by LG Life Sciences Laboratory (Lot # WVX 16014), produced at KOREA. The doses of 1 ml will
Biological/vaccine
C23.550.340.500

Sponsors

Faculdade de Enfermagem Universidade Federal de Goiás
Lead Sponsor
Fundação de Amparo à Pesquisa do Estado de Goiás
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Susceptible to infection by hepatitis B virus infection (anti-HBs marker alone); Being male; Age between 18 years; Prison regime in the Regional Prison of Itumbiara with penalty expected for more than eight months.

Exclusion criteria

Exclusion criteria: To present any clinical picture that contraindicates hepatitis B vaccination; Effect of substances that compromise the data response and the integrity of the researchers; Medical diagnosis of mental disorders; Present at the time of data collection behavior that endangers the physical and / or emotional health of the researcher. To present difficulty of understanding in order to respond to the instrument of data collection (auditory deficiency and / or altered speech).

Design outcomes

Primary

MeasureTime frame
Serum titre of quantitative anti-HBs antibodies (greater than 10 mIU / mL = protective titres) determined after the hepatitis B vaccination schedule is expected. Blood will be collected 30 to 45 days after the last dose of the vaccine and will be evaluated by the electrochemiluminescence assay.

Secondary

MeasureTime frame
The level of pain less than 10 (worse pain) reported after the administration of each dose of the vaccine is expected using the analog pain scale;It is expected that the individual will not reattagenicity after each dose of hepatitis B vaccine given;It is expected that sex, age, obesity, smoking and autoimmune diseases alter titration response (less than 10 mIU / mL) after vaccination. The SPSS 13.0 program will be used

Countries

Brazil

Contacts

Public ContactMarcos de Matos

Universidade Federal de Goiás

marcosmatos@ufg.br+55-62-984376296

Outcome results

None listed

Source: REBEC (via WHO ICTRP)