CTRI/2026/01/102496尚未招募不适用
Evaluation of safety and efficacy of intradermal administration of vaccines using indigenous microneedles: A pre-clinical study in mice, followed by clinical study in human beings.
Indian Council of Medical Research (ICMR)1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年2月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
研究概览
简要总结
This trial aims to compare the safety and immunogenicity of intradermal administration of vaccines using microneedles, in comparison to conventional intramuscular injection, and intradermal administration using hypodermic needles, in human subjects in an age-de-escalating manner, i.e. adults, followed by adolescents, followed by school-age children, followed by older infants, followed by young infants. Extensive animal experiments in three mammalian models (mice, guinea pig and rats) have confirmed pre-clinical safety and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.50 Month(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adult volunteers (age 18-50 years old) Healthy adolescent volunteers (10-17.9 years old) Healthy children (5-6 years old) eligible for DPT vaccine booster dose Healthy infants (18-24 months old) eligible for DPT vaccine booster dose Healthy young infants (14-18 weeks old) eligible for third dose of Pentavalent vaccine.
排除标准
- •Age group:18-50 years old (adults) • Current pregnancy • Current lactation • Known immune-deficiency state • Recipient (past, present or anticipated) of corticosteroids or immune-modulating medications • Recent or anticipated surgery (within 6 months) • Previous history of tetanus
- •Age group:10-17.9 years old (adolescents) • Known immune-deficiency state • Recipient (past, present or anticipated) of corticosteroids or immune-modulating medications.
- •• Recent or anticipated surgery (within 6 months) • Previous history of tetanus
- •Age group: 5-6 years old (children) • Known immune-deficiency state • Recipient (past, present or anticipated) of corticosteroids or immune-modulating medications • Recent or anticipated surgery (within 6 months) • Previous history of diphtheria or pertussis or tetanus
- •Age group:18-24 months old (old infants) • Known immune-deficiency state • Recipient (past, present or anticipated) of corticosteroids or immune-modulating medications • Recent or anticipated surgery (within 6 months) • Previous history of diphtheria or pertussis or tetanus • Development delay • Any past or present neurological illness • Feeding difficulty • Any illness involving the cardio-respiratory system
- •Age group:14-18 weeks old (young infants) • Known immune-deficiency state • Recipient (past, present or anticipated) of corticosteroids or immune-modulating medications • Recent or anticipated surgery (within 6 months) • Previous history of diphtheria or pertussis or tetanus or Hepatitis B or Hib disease • Development delay • Any past or present neurological illness • Feeding difficulty • Any illness involving the cardio-respiratory system.
研究者
Dr Joseph L Mathew
Postgraduate Institute of Medical Education and Research (PGIMER)Chandigarh
研究点 (1)
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