Table 1.
Study characteristics.
| Studies | Country | Multi-center? | Centralized manufacture protocol? | Malignancy | Stage | Patients (n) | Recruitment Period | Follow up period | Previous interventions | Vaccine name | Trial sponsor | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control | Vaccine Group | ||||||||||||
| enrolled | vaccinated | ||||||||||||
|
Oh (2020) Oh (2016) |
USA | Yes | Yes | Ovarian | III, IV+ | 11 | 20 (31)° | 20 (31)° | 2011–2015 | Median 43.4mo (10.1–77.6mo) | No | Vigil® | Gradalis, Inc |
| Bota (2018) | USA | No | NA | Glioblastoma | IV+ | 4† | 5† | 5† | NR | NR | Surgery, chemotherapy, radiotherapy | ERC1671 (Gliova™) | Eiptopoietic Research Corporation |
| Schulze (2009) | Germany | Yes | NR | Colon | I–IV+ | 25 | 25 | 25 | 1991–1998 | Mean (+/− SD): 116.1 ± 23.8mo vaccine, 112.4 ± 18.5 control | Surgery, chemotherapy, radiotherapy for synchronous / metachronous colon or rectal cancer | N/A | Unclear |
| Peng (2006) | China | No | NA | HCC | I, II | 35 | 40 | 32 | 1999–2003 | Median +/− SD: 33.6 ± 8.7 | NR | N/A | Science Developing Plan Fund of Guandgong Province |
| Uyl-de Groot (2005), Vermorken (1999) | Netherlands | Yes | Yes | Colon | II, III | 126 | 128 | 128 | 1987–1996 | Median 5.8 years | No | OncoVAX | Intracel Corporation |
| Peng (2005) | China | No | NA | HCC | I–III | 26 | 30 | 24 | 2000–2003 | Median > 42 months | NR | N/A | Natural Science Foundation of Guangdong Province |
| Kuang (2004) | China | No | NA | HCC | I–III | 21 | 19 | 18 | 2001–2003 | Median 15 months (8–28) | NR | N/A | Ministry of Education, Culture, Sports, Science and Technology of Japan |
| Harris (2000) | United States | Yes | No | Colon | II, III | 153 | 205 | 205* | 1986–1993 | Median 7.6 years | No | N/A |
Public Health Service Grants (National Cancer Institute, National Institute of Health, Department of Health and Human Services) Intracel |
| Galligioni (1996) | Italy | NR | NR | RCC | I–III | 54 | 60 | 60 | 1987–991 | 61 months | NR | N/A | Unclear |
| Hoover (1993) | United States | Yes | No | Colon / Rectum | I–III | 39 | 50 | 41 | 1981–1990 | Median 93 months (colon), 57 months (rectal) | None within 5 years of enrolment | N/A |
National Institutes of Health Organon Teknika/Biotechnology Research Institute |
| Gray (1989, 1988) | Australia | Yes | Yes | Colon / Rectum | II, III | 145 | 148 | 129 | 1978–1981 | 5 years | NR | N/A | Unclear |
| Adler (1987) | Israel | NR | NR | RCC | I–IV+ | 19 | 24 | 24 | 1980–1985 | Median 30 months | NR | N/A | Frieda and Shmuel Sharfhartz Memorial Cancer Research Fund |
| Souter (1981) | United Kingdom | NR | NR | Lung | I, II | 49 | 46 | 34 | NR | NR | No | N/A | Cancer Research Campaign Grant |
| Embleton (1978), McIllmurray (1977) | United Kingdom | No | NA | Melanoma | II | 7 | 8 | 8 | NR | 12 months | No | N/A | Cancer Research Campaign Grant |
NA not applicable, NR not reported, HCC Hepatocellular Carcinoma, RCC Renal Cell Carcinoma.
°In the study by Oh (2016), 20 patients were randomized to the treatment group and 11 to the control; subsequently 10 additional patients were de-randomized and placed into treatment group. Our survival analysis focusses only on those who were randomized.
†Numbers from interim analysis.
*Although 205 patients were vaccinated, only 150 patients were deemed “analyzable” based on adequacy of vaccines and sufficient follow up information.