Thymosin alpha-1 in immune modulation and adjunctive immunotherapy — evidence extract
The Institute's graded assessment of Thymosin alpha-1 for immune modulation and adjunctive immunotherapy, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Immune modulation and adjunctive immunotherapy
§1.1Question and anchor outcome
- Population
- Pharmacological modification of innate or adaptive immune function, assessed by cell counts, functional assays and clinical infection or oncological endpoints.
- Intervention
- Thymosin alpha-1, subcutaneous
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- CD4 and CD8 counts
Additional outcomes the Institute extracts for this indication: Response to vaccination; Infection incidence; Tumour response where applicable.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Thymosin alpha-1 in immune modulation and adjunctive immunotherapy.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| TA1-HBV-1 | 3 | Randomised, double-blind, active-controlled | — | 52 weeks | 2001 |
| TA1-HCV-1 | 3 | Randomised, double-blind, active-controlled | — | 48 weeks | 2004 |
| TA1-VACCINE-ELDERLY | 2 | Randomised, double-blind, placebo-controlled | — | 8 weeks | 1998 |
| TA1-SEPSIS-CN | 3 | Randomised, double-blind, placebo-controlled | 361 | 28 days | 2013 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | Serious | The enrolled population differs materially from the population of the assessment question. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Moderate certainty. The true effect is likely to be close to the estimate, but there is a possibility that it is substantially different. Further research is likely to have an important impact on confidence in the estimate. | ||
§1.4What this extract does not establish
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Garaci E, Pica F, Serafino A, Balestrieri E, Matteucci C, Moroni G, Sorrentino R, Zonfrillo M, Pierimarchi P, Sinibaldi-Vallebona P. Thymosin α1 and cancer: action on immune effector and tumor target cells. Annals of the New York Academy of Sciences 2007;1112:225–234. doi:10.1196/annals.1415.025 · PMID 17567944
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
- Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, Shamseer L, Tetzlaff JM, Akl EA, Brennan SE, Chou R, Glanville J, Grimshaw JM, Hróbjartsson A, Lalu MM, Li T, Loder EW, Mayo-Wilson E, McDonald S, McGuinness LA. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi:10.1136/bmj.n71 · PMID 33782057
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.